_______________________
PRODUCT
New Choice brand Mini Fruity
Gels, packaged in individual serving
plastic cups with foil lids, ca.
17 gms per cup. The mini-gel cups
are packaged in 10 oz. plastic bags,
30 bags per carton and in 1500 gm
plastic jars, 6 jars per carton.
Products are coded with order numbers
only:
872886 Mini Gels Taro Flavor (Bag)(30x10
oz.)
872888 Mini Gels Taro Flavor (Jar)(6x1500
Gm)
Recall # F-728-2;
872890 Mini Gels Lychee Flavor (Bag)
(30x10 oz.)
872892 Mini Gels Lychee Flavor (Jar)(60x1500
Gm)
Recall # F-729-2;
872895 Mini Gels Mango Flavor (Bag)
(30x10 oz.)
872897 Mini Gels Mango Flavor (Jar)(60x1500
Gm)
Recall # F-730-2;
872898 Mini Gels Assorted Flavor
(Bag) (30x10 oz.)
872899 Mini Gels Assorted Flavor
(Jar)(60x1500 Gm)
Recall # F-731-2.
CODE
All products on the market at the
time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastland Food Corporation,
Columbia, MD, by visits beginning
January 1, 2002.
Manufacturer: Sheng Hsiang Jen Foods
Co. Ltd., Taichung Port, Taiwan.
State initiated recall is complete.
REASON
This type of candy is in violation
of section 402(a)(3) of the Federal
Food, Drug, and Cosmetic Act in that
it is unfit for food due to the characteristics
that result in a serious choking
hazard.
VOLUME OF PRODUCT IN COMMERCE
9645 cartons.
DISTRIBUTION
24 states east of the Mississippi
River and the D.C.
_______________________
PRODUCT
ABC Brand Mini Gel Cups, packed
30/14 oz. cello pkgs. to a case,
in six varieties:
a) Durian Cocode Nut Jelly, Recall
# F-732-2;
b) Gueiling Gau Cocode Nut Jelly,
Recall # F-733-2;
c) Peach Cocode Nut Jelly, Recall
# F-734-2;
d) Taro Cocode Nut Jelly, Recall
# F-735-2;
e) Lychee Cocode Nut Jelly, Recall
# F-736-2;
f) Mango Cocode Nut Jelly, Recall
# F-737-2.
CODE
All products on the market at the
time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Everlasting Distributors,
Inc., Bayonne, NJ, by letter on February
1, 2002.
Manufacturer: Tsang Lin Industries
Corp., Talchung City, Taiwan.
Firm initiated recall is complete.
REASON
This type of candy is in violation
of section 402 (a)(3) of the Federal
Food, Drug, and Cosmetic Act, that
it is unfit for food due to the characteristics
that result in a serious choking
hazard.
VOLUME OF PRODUCT IN COMMERCE
1197 cases x 30/14oz.pkgs.
DISTRIBUTION
NY, MA, IL, FL, GA, MD, NJ, PA and
VA.
_______________________
PRODUCT
Assorted Mini-Fruit Bites. Recall
# F-738-2.
Sold under two brands:
a) Labeled in part: "MOTHER'S PRIDE
BELIEVE IN THE BEST Assorted MINI-FRUIT
BITES***NET WEIGHT/1500G***CAREFULLY
AND EXCLUSIVELY MADE FOR BUDGET PROMOTIONS
CO LTD HOUSTON TEXAS U.S.A. AND TORONTO
CANADA Made in Taiwan***CAUTION***THIS
PRODUCT CONTAINS FRUIT CHUNKS, MUST
BE CHEWED THOROUGHLY BEFORE SWALLOWING.
NOT RECOMMENDED FOR CHILDREN UNDER
3 YEARS OLD." This product is packaged
in a rigid, clear plastic bottle.
b) Labeled in part: "NATA Assorted
MINI-FRUIT BITES". This product is
packaged in a plastic bag whose major
background color is purple.
Mango Mini-Fruit Bites. Recall #
F-739-2.
Sold under two brands:
a) Labeled in part: "MOTHER'S PRIDE
BELIEVE IN THE BEST
Mango MINI-FRUIT BITES***NET WEIGHT/1500G***CAREFULLY
AND EXCLUSIVELY MADE FOR BUDGET PROMOTIONS
CO LTD HOUSTON TEXAS U.S.A. AND TORONTO
CANADA Made in Taiwan***CAUTION***THIS
PRODUCT CONTAINS FRUIT CHUNKS, MUST
BE CHEWED THOROUGHLY BEFORE SWALLOWING.
NOT RECOMMENDED FOR CHILDREN UNDER
3 YEARS OLD." This product is packaged
in a rigid, clear plastic bottle.
b) Labeled in part: "NATA Mango MINI-FRUIT
BITES***Net
Weight***300g". This product is packaged
in a plastic bag with whose major
background color is green.
Lychee Mini-Fruit Bites. Recall
# F-740-2. Sold under two brands:
a) Labeled in part: "MOTHER'S PRIDE
BELIEVE IN THE BEST
Lychee MINI-FRUIT BITES***NET WEIGHT/1500G***CAREFULLY
AND EXCLUSIVELY MADE FOR BUDGET PROMOTIONS
CO LTD HOUSTON TEXAS U.S.A. AND TORONTO
CANADA Made in Taiwan***CAUTION***THIS
PRODUCT CONTAINS FRUIT CHUNKS, MUST
BE CHEWED THOROUGHLY BEFORE SWALLOWING.
NOT RECOMMENDED FOR CHILDREN UNDER
3 YEARS OLD." This product is packaged
in a rigid, clear plastic bottle.
b) Labeled in part: "NATA Lychee
MINI-FRUIT BITES". This product is
packaged in a plastic bag with whose
major background color is peach.
CODE
All products on the market at the
time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Budget Promotions,
Inc., Houston, TX, by telephone and
letters beginning December 5, 2001.
Manufacturer: Tsang Lin Industries
Corporation, Shie-Ho Li, Taichung
City, Taiwan. FDA initiated recall
is complete.
REASON
This type of candy is in violation
of section 402(a)(3) of the Federal
Food, Drug, and Cosmetic Act in that
it is unfit for food due to the characteristics
that result in a serious choking
hazard.
VOLUME OF PRODUCT IN COMMERCE
1,200 cartons.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
"Caravelle Brand Preserved Coconut
Product of Vietnam"; 7 ounce; packaged
in clear plastic trays. Recall #
F-741-2.
CODE
All products on the market at the
time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Anhing Corporation, Los Angeles,
CA, by letters on February 25, 2002.
State initiated recall is complete.
REASON
The New York State Department of
Agriculture and Markets found the
product to contain undeclared sulfites
and colors.
VOLUME OF PRODUCT IN COMMERCE
173 cartons.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
FORTUNER'S Selected Food brand
DRIED SWEET POTATO packed in flexible
plastic bags, Net Wt. 7 oz. (198
g). MADE IN CHINA. Recall # F-742-2.
CODE
No codes. All products on the market
at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Star Mark Management,
Inc., Brooklyn, NY, by press release
on February 21, 2002 and by letter
on March 1, 2002.
Manufacturer: Unknown. Stated initiated
recall is complete.
REASON
The New York State Department of
Agriculture and Markets found the
product to contain undeclared sulfites
(928 ppm).
VOLUME OF PRODUCT IN COMMERCE
3 cases (100 bags per case).
DISTRIBUTION
NY.
_______________________
PRODUCT
ICE CREAM CONE product labeled
on the principal display panel
as: "Perry's Ice Cream *** NUTTY
CONES *** No Sugar Added ***
Reduced Fat *** Light Vanilla Ice
Cream, Chocolate Flavored
Topping, and Peanuts in a Crispy
Cone ***" Recall # F-743-2.
CODE
2222
3216
3219
3225
4223
4227
5217
5224
UPC CODE: 0 75767
82042 0.
RECALLING FIRM/MANUFACTURER
Perry's Ice Cream Co. Inc., Akron,
NY, by telephone on July 12, 2002.
Firm initiated recall is ongoing.
REASON
The product contains undeclared peanuts,
which are obviously visible.
VOLUME OF PRODUCT IN COMMERCE
30,000 cartons (approx.).
DISTRIBUTION
NY and PA.
_______________________
PRODUCT
J.C. Taste brand Oriental Mix,
net wt. 4.80 oz. packed in a rigid
plastic container. Ingredients: Rice
Crackers, chile bits, sesame sticks,
almonds, green pea, filberts, cashews,
walnuts. Recall # F-744-2.
CODE
Sell by 09-08-02.
RECALLING FIRM/MANUFACTURER
Hy Grade Nut, Brooklyn, NY, by visit
on April 25, 2002.
State initiated recall is complete.
REASON
The New York State Department of
Agriculture and Markets found the
product to contain undeclared FD&C
Yellow #5, Yellow #6, and Blue #1.
VOLUME OF PRODUCT IN COMMERCE
12 packages.
DISTRIBUTION
NY.
_______________________
PRODUCT
Florida Natural Brand Premium
NOT FROM CONCENTRATE PASTEURIZED
HOME SQUEEZED STYLE WITH PULP 100%
Pure Florida Orange Juice, 64 oz.
Carton. Recall # F-745-2.
CODE
December 01 01.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Citrus World aka
as Florida Natural Growers, Inc.,
Lake Wales, FL, by letter and fax
beginning on October 25, 2001.
Manufacturer: World Citrus West,
Inc., Fullerton, CA.
Firm initiated recall is complete.
REASON
The product may be contaminated with
yeast.
VOLUME OF PRODUCT IN COMMERCE
5197 8/64 oz cases.
DISTRIBUTION
AZ, NV, CA, OR and WA.
_______________________
PRODUCT
Premarin (conjugated estrogen
tablets USP). 1.25 mg tablets,1000
and 5,000-tablet bottles. Recall
# D-058-2.
CODE
NDC #: 0046-0866-91 (bottles of 1000)
Lot #s: 9000353, exp. 11/04 and 9000681,
exp. 11/04.
RECALL EXTENDED ON 6/18/02 to the following 3 lots
NDC #: 0046-0866-81 (bottles of
100)
Lot #: 9000477, Exp. 1/05
Distribution dates: 6/12/00-8/17/01
Quantity mfr'd: 31,310 bottles
Quantity distributed: 31,310 bottles
NDC #: 0046-0866-91 (bottles of
1000)
Lot #: 9000682, Exp. 1/05
Distribution dates: 7/10/00 - 5/2/01
Quantity mfr'd: 2,160 bottles
Quantity distributed: 2,132 bottles
NDC #: 0046-0866-95 (bottles of 5000)
Lot #: 9000481, Exp. 1/05
Distribution dates: 7/6/00 - 3/13/01
Quantity mfr'd: 1,308 bottles
Quantity distributed: 1,308 bottles
----------------------------------------
RECALL EXPANDED 7/16/02:
The following lots represent Batch
R987005 which was manufactured January
1998.
NDC #: 0046-0866-91 (bottles of 1000)
Lot # 9980654, Exp. 1/03
Distribution dates: July 1998 - March
1999
Quantity mfr'd: 3,859 units
Quantity distributed: 3,858 units
(of which 3,292 units went to wholesale
customers)
NDC #: 0046-0866-95
Lot #: 9980653, Exp. 1/03
Quantity mfr'd: 1,604 units
Quantity distributed: 1,604 units
(of which 648 units went to wholesale
customers).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth-Ayerst Laboratories,
Richmond, VA, by letter dated November
21, 2001.Manufacturer: Ayerst Laboratories,
Inc., Rouses Point, NY.Firm initiated
recall is ongoing.
REASON
Failure to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
10,285 bottles.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Premarin Tablets (conjugated
estrogens tablets, USP), 1.25 mg,
100 tablet bottles, Rx only. Recall
# D-358-2.
CODE
Lot #9000481D, Exp. 01/05
(extended recall on 7/18/2002)
Lot #9980653, Exp. 01/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: National Pharmpak
Services, Inc., Zanesville, OH, by
letter on June 19, 2002.
Manufacturer: Ayerst Laboratories,
Inc., Rouses Point, NY.Firm initiated
recall is ongoing.
REASON
Failure to meet USP dissolution specifications
by manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE
9,601 bottles (lot #9000481);8,800
bottles (lot #9980653)-extension.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
a) Ferrex 150 Forte Capsules, Rx ONLY, 100 UNIT DOSE CAPSULES,
(Each capsule contains: Iron 150 mg, Folic Acid 1 mg,
Vitamin B12 25 mcg), NDC 51991-198-11, 10 blister packs,
10 capsules per blister pack. Recall # D-381-2;
b) Vinate Ultra Prenatal Vitamin and Mineral Supplement, tablets,
Rx ONLY, 100 UNIT DOSE TABLETS, NDC 51991-154-11, 10 blister packs, 10 tablets per blister pack. Recall # D-382-2.
CODE
a) lot 021869, exp. 3/2004, NDC 51991-198-11;
b) lot 014247, exp. 10/2003, NDC 51991-154-11.
RECALLING FIRM/MANUFACTURER
Contract Pharmacal Corporation, Hauppauge, NY, by letters on June 19, 2002. Firm initiated recall is ongoing.
REASON
Mislabeled; Exterior carton product names ( Ferrex 150/Vinate Ultra ) differs from blister package product names (Poly-Iron 150/Ultra Natal).
VOLUME OF PRODUCT IN COMMERCE
a) 52,334 blister packs total, which were packaged into unit cartons, 10 blister packs per carton
b) 881 unit cartons.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Equate Extra Strength Pain Relief PM Gelcaps (Acetaminophen 500 mg. and Diphenhydramine HCl 25 mg)100 count bottles
Recall # D-383-2.
CODE
Lot 1MB1451.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products, Carson, CA, by letter on July 17, 2002.
Manufacturer: Leiner Health Products, Wilson, NC.
Firm initiated recall is ongoing.
REASON
Contamination; gelcaps may contain plastic/gasket material.
VOLUME OF PRODUCT IN COMMERCE
41,040 bottles.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Iodine Tincture, USP Solution
(sodium iodide 2.4%, iodine 2%) 1
oz. Bottle. This product was distributed
only under the Kroger brand. Recall
# D-384-2.
CODE
Lot 2611, Exp. 01/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rush & Hebble
Co., Inc., Edinburgh, IN, by telephone
on July 26, 2002.Manufacturer: Century
Pharmaceuticals, Indianapolis, IN.Firm
initiated recall is ongoing.
REASON
Labeling; bottles labeled as Iodine
Tincture contain Curechrome (benzalkonium
chloride).
VOLUME OF PRODUCT IN COMMERCE
4,423 bottles.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Levothroid Tablets (levothyroxine
sodium tablets, USP),25-mcg.,100-tablet
bottles, Rx Only, NDC #0456-0320-01.Recall
# D-385-2.
CODE
Lot #120012, Exp. 12/02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals,
Inc., St. Louis, MO, by letters dated
February 27, 2002.
Manufacturer: Forest Pharmaceuticals,
Inc., Cincinnati, OH.
Firm initiated recall is ongoing.
REASON
Stability; low potency prior to expiration.
VOLUME OF PRODUCT IN COMMERCE
14,415/100-tablet bottles.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Source Plasma, Recall # B-1660-2.
CODE
Units
33-Y52355, 33-ZBY627, 33-ZBY772,
33-Y52621, 33-Y52699,
33-ZB2688, 33-ZB2870, 33-ZB3049,
33-ZB3222, 33-ZB3337,
33-ZB3466, 33-ZGM313, 33-3JX151,
33-3JZ216, 33-3JZ288,
33-3JZ404, 33-3JZ577, 33-3JZ835,
33-3J0084, 33-3J0152,
33-3J0241, 33-2V0018, 33-84I141,
33-84I224, 33-84I437,
33-84I619, 33-84I720, 33-84I954,
33-84J132, 33-84K037,
33-84K152, 33-84K339, 33-84K468,
33-84K666, 33-84K797,
33-84L319, 33-84L433, 33-84L643,
33-84L791, 33-84L980,
33-84M120, 33-84M425, 33-84M610,
33-84M732, 33-84M928,
33-84N089, 33-84N452, 33-84N603,
33-84N773, 33-84O231,
33-84O312, 33-84O571, 33-84O643,
33-84O887, 33-84O963,
33-84P145, 33-84P254, 33-84P411,
33-84P513, 33-84P684,
33-84P793, 33-84P952, 33-84Q087,
33-84Q327, 33-84Q501,
33-84Q576, 33-84Q757.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services,
Inc., Knoxville, TN, by letter dated
September 3, 2001 or September 4,
2001.
Manufacturing Firm: Aventis Bio-Services,
Inc., West Allis, WI.Firm initiated
recall is complete.
REASON
Blood products, collected from a
donor who had engaged in high risk
behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
IL and Germany.
_______________________
PRODUCT
CryoGraft Left Medial Femoral
Condyle (1 allograft), Model No.
FC30, Recall # B-1726-2.
CODE
Serial Number 7707353.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by
letter dated March 15, 2002.Firm
initiated recall is ongoing.
REASON
Tissue repair product, processed
outside of processing timelines,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.
_______________________
PRODUCT
Red
Blood Cells, Leukoreduced, Recall
# B-1727-2.
CODE
Unit 12P23867.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Regional
Blood Services, Charlotte, NC, by
letter dated May 6, 2002. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor
whose hemoglobin level was documented
as unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________
PRODUCT
Source Plasma, Recall # B-1728-2.
CODE
Unit 71528373.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Champaign, IL, by fax on December 19, 2001. Firm initiated recall is complete.
REASON
Blood product, which had an elevated ALT test result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________
PRODUCT
a) Platelets, Recall # B-1729-2;b)
Fresh Frozen Plasma, Recall # B-1730-2.
CODE
a) and b) Unit GP43332.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA,
by telephone on October 6, 2001.
Firm initiated recall is complete.
REASON
Blood products, corresponding to
a unit of Red Blood Cells that was
possibly contaminated with coagulase
negative Staphylococcus sp.
bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
_______________________
PRODUCT
Source Plasma, Recall # B-1731-2.
CODE
Units XIW251, 4FY613, Z9S282, Z7N503, 4FZ391, 7MR753.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Kansas City, MO, by fax on May 31 or June 1, 2000. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis B surface antigen (HbsAg)but collected from a donor who previously tested reactive for HbsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL, Germany and Switzerland.
_______________________
PRODUCT
a)Red Blood Cells, Leukoreduced,
Recall # B-1732-2;b)Recovered Plasma,
Recall # B-1733-2.
CODE
a) and b) Units 09FK21597, 09FK10783
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services,
Midwest Region, Omaha, NE, by e-mail
or letter dated January 8, 9 and
11, 2001 or February 13, 2001. Firm
initiated recall is complete.
REASON
Blood products, which tested negative
for viral markers, but were collected
from a donor that subsequently admitted
to a previous positive test for HIV,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NE, Puerto Rico and Switzerland.
_______________________
PRODUCT
Red Blood Cells, Leukoreduced,
Recall # B-1749-2.
CODE
Units 41FL88756, 41FL88365.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services,
Alabama Region, Birmingham, AL, by
letter dated December 4, 2000 and
January 9, 2001.Firm initiated recall
is complete.
REASON
Blood products, collected from a
donor who reported having lived in
an area designated as endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.
_______________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1750-2.
CODE
Units 41GE54819.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Alabama Region, Birmingham, AL, by telephone on December 26, 2000 and letter dated December 29, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1751-2.
CODE
Units 41GE54840.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Alabama Region, Birmingham, AL, by telephone on December 26, 2000 and by letter dated December 29, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________
PRODUCT
Source Plasma, Recall # B-1772-2.
CODE
Units 04FK27144, 04FK10531.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by inquiry letter on April 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeld Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA and Switzerland.
_______________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-1773-2;
b) Cryoprecipitate, Recall # B-1774-2;
c) Recovered Plasma, Recall # B-1775-2.
CODE
a); b) and c) Unit FK53666.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services Inc., dba Rhode Island Blood Center, Providence, RI, by letter or fax on April 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to medication with the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
RI and Switzerland.
_______________________
PRODUCT
Platelets, Pheresis, Recall #
B-1776-2.
CODE
Units (2 units) 04GS05536 - split
unit.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region,
Dedham, MA, by telephone on March
2, 2002 and by letter dated March
18, 2002.Firm initiated recall is
complete.
REASON
Blood products, collected in a manner
that compromised their sterility,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.
_______________________
PRODUCT
Platelets, Recall # B-1778-2.
CODE
Unit 7101304.
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter dated February 19, 2002. Firm initiated recall is complete.
REASON
Platelets, manufactured with a shortened rest time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.
_______________________
PRODUCT
Platelets, Pheresis, Leukocytes
Reduced, Irradiated,Recall # B-1779-2.
CODE
Unit 003FK22138.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services,
Southern Region, Atlanta, GA, by
letter dated August 30, 2001. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor
who reported travel to an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1781-2.
CODE
Unit 04K28513.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by letter dated April 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
_______________________
PRODUCT
a) Red Blood Cells, Recall #
B-1782-2;b) Platelets, Recall # B-1783-2.
CODE
a) Units 1164509, 1157972;b) Unit
1157972.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH,
by letter dated April 22, 2002. Firm
initiated recall is complete.
REASON
Blood products, collected from a
donor who reported travel to an area
designated as endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH and IN.
_______________________
PRODUCT
Red Blood Cells, Recall # B-1784-2.
CODE
Unit 0815676.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated March 14, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________
PRODUCT
Red Blood Cells, Deglycerolized, Recall # B-1785-2.
CODE
Unit 0636242.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated March 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1786-2.
CODE
Unit 04G29868.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by letter dated May 15, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________
PRODUCT
Red Blood Cells, Recall # B-1787-2.
CODE
Unit 21KS04045.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by letter dated April 8, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.
_______________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-1790-2.
b) Red Blood Cells, Leukocytes Reduced
Irradiated, Recall # B-1791-2.
CODE
a) Unit numbers 8715298, 8715300,
8715302, 8715303, 8715304, 8715306,
8715307, 8715310, 8715311, 8715312,
8715313, 8715315, 8715316, 8715319,
8715320, 8715321, 8715322, 8715323,
8715324, 8715325, 8715326, and 8715327;b)
Unit number 8715298.
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc.,
Amarillo, TX, by letter dated November
7, 2001. Firm initiated recall is
complete.
REASON
Blood products, incorrectly tested
for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
TN and TX.
_______________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1792-2;
b) Recovered Plasma, Recall # B-1793-2.
CODE
a) and b) Unit number 17196-7521.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by letters on December 31, 2001 and January 11, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and CA.
_______________________
PRODUCT
a) Red Blood Cells, Recall #
B-1794-2;b) Fresh Frozen Plasma,
Recall # B-1795-2.
CODE
a) Unit numbers 15169-5378, 15169-5363,
15169-5365, 15169-5367, 15169-5368,
15169-5369, 15169-5374, 15169-5375,
15169-5376, and 15169-5377;
b) Unit numbers 15169-5378, 15169-5363,
15169-5365, 15169-5367, 15169-5368,
15169-5369, 15169-5374, 15169-5375,
15169-5376, 15169-5377, 15169-5360,
and 15169-5364.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Hot Springs,
AR, by telephone on October 25, 2001
and by letter dated November 27,
2001. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested
for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
AR.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1796-2.
CODE
Unit numbers 24208-2763, 24208-2790, 24208-2799, 24208-2804, 24208-2812, 24208-2833, 24208-2844, 24208-2866, 24208-2867, 24208-2868, 24208-2874, 24208-2877, 24208-2882, 24208-2883, 24208-2886, 24208-2889, 24208-2898, 24208-2899, 24208-2901, 24208-2902, 24208-2904, 24208-2905, 24208-2907, 24208-2908, 24208-2909, 24208-2910, 24208-2911, 24208-2912, 24208-2914, 24208-2915, 24208-2916, 24208-2917, 24208-2918, 24208-2920, 24208-2921, 24208-2922, 24208-2923, 24208-2924, 24208-2926, 24208-2934, 24208-2942, 24208-2943, 24208-2946, 24208-2948, 24208-2949, 24208-2950, 24208-2952, 24208-2954, 24208-2955, 24208-2957, 24208-2959, 24208-2962, 24208-2963, 24208-2964, 24208-2965, 24208-2966, 24208-2967, 24208-2968, 24208-2970, 24208-2971, 24208-2972, 24208-2973, 24208-2974, 24208-2975, 24208-2976, 24208-2977, 24208-2978, 24208-2979, 24208-2980, 24208-2981, 24208-2983, 24208-2984, 24208-2985, 24208-3502, 24208-3504 and 24208-3505.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by telephone on July 25 and 27, 2000 and August 2, 2000 and by letter dated September 5, 2000. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were collected in the incorrect size collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
76 units.
DISTRIBUTION
SD, WY and NE.
_______________________
PRODUCT
Red Blood Cells, Recall # B-1799-2.
CODE
Unit number S07455.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by
letter on August 15, 2000.Firm initiated
recall is complete.
REASON
Blood product, collected from an
unsuitable donor based on living
in an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________
PRODUCT
Red Blood Cells, Recall # B-1800-2.
CODE
Unit number E77937.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by
letter on July 10, 2001.Firm initiated
recall is complete.
REASON
Blood product, collected from an
unsuitable donor based on travel
to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Recall # B-1801-2.
CODE
Unit number 22423-3091.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV,
by telephone on June 1, 2001.Firm
initiated recall is complete.
REASON
Blood product, collected from an
unsuitable donor based on travel
to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1802-2.
CODE
Unit number 42FG87615.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter dated November 26, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-1803-2;b)
Platelets, Recall # B-1804-2.
CODE
a) and b) Unit number 1853532.
RECALLING FIRM/MANUFACTURER
South Texas
Blood and Tissue Center, San Antonio,
TX, by telephone and fax on November
19 and 28, 2001.Firm initiated
recall is complete.
REASON
Blood products, collected from an
unsuitable donor based on travel
to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________
PRODUCT
Source Plasma, Recall # B-1752-2.
CODE
Unit 56992922.
RECALLING FIRM/MANUFACTURER
Recalling Firm: SeraCare, Inc., Colorado
Spring, CO, by letter dated November
29, 2001.Manufacturer: SeraCare,
Inc., SeraCare Acquisitions, Inc.,
Pasco, WA. Firm initiated recall
is complete.
REASON
Blood product, collected from a donor
whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Irradiated,Recall # B-1777-2.
CODE
Units 22420-9642, 22421-0866, 22421-0795,
22421-3752.
RECALLING FIRM/MANUFACTURER
United Blood Services, Las Vegas,
NV, by telephone on March 7, 2001
or by letter dated March 28, 2001.
Firm initiated recall is complete.
REASON
Blood products, that lacked assurance
of proper storage temperatures due
to inaccurate documentation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NV.
_______________________
PRODUCT
Source Plasma, Recall # B-1797-2.
CODE
Unit number DZDHRX.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services,
Inc., Knoxville, TN, by letter dated
April 10, 2002.Manufacturer: Aventis
Bio-Services, Inc., Eugene, OR.Firm
initiated recall is complete.
REASON
Blood product, collected from a donor
whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________
PRODUCT
Source Plasma, Recall # B-1798-2.
CODE
Unit number DZBMDV.
RECALLING FIRM/MANUFACTURER
+Recalling Firm: Aventis Bio-Services,
Inc., Knoxville, TN, by letter dated
April 10, 2002.Manufacturer: Aventis
Bio-Services, Inc., Eugene, OR.Firm
initiated recall is complete.
REASON
Blood product, collected from a donor
whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________
PRODUCT
a) Ulnar Implant, standard
stem, Sizes 1 thru 4. Catalog numbers
UHA-S1 thru UHA-S4. Recall # Z-1215-2;
b) Ulnar Implant, stem, 20mm collar,
Sizes 1 thru 4. Catalog numbers UHA-S120
thru UHA-S420. Recall # Z-1216-2.
CODE
Lot numbers US0001 thru US0054 for
stand alone device Distal Ulnar Stem
with extended collar.
It is included in a Kit called an
"Ulnar Head Kit" Catalog No. UHA-KIT.
Which is also under recall.
Kit contains 4 head sizes, 4 stem
sizes with regular collars and 4
stem sizes with extended collars.
Additionally, as a precaution, firm
is recalling the following Catalog
Numbers:
UHA-S1 thru UHA-S4 which are four
sizes of Distal Ulnar Stems.
UHA-S120, UHA-S220, UHA-S320, UHA-S420
which are four sizes of Distal Ulnar
Stem with extended collar.
RECALLING FIRM/MANUFACTURER
Avanta Orthopaedics, Inc., San Diego,
CA, by letter dated April 8, 2002.
Firm initiated recall is complete.
REASON
Sterility, extended collar stems
break through peel pouch.
VOLUME OF PRODUCT IN COMMERCE
252.
DISTRIBUTION
KY and Internationally.
_______________________
PRODUCT
Baxter Basal/Bolus Infusor, 0.5
x 2mL/hr, a portable elastomeric
infusion system; 6 units per case.
Recall # Z-1221-2.
CODE
Product code 2C1955KJ, lot 00N040,
Exp. Dec 31 2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare
Corp., Round Lake, IL, by telephone
and letter on June 17, 2002.
Manufacturer: Baxter Healthcare Corp.,
Irvine, CA. Firm initiated recall
is ongoing.
REASON
Possible overinfusion.
VOLUME OF PRODUCT IN COMMERCE
2502 units.
DISTRIBUTION
PA, Japan and South Africa.
_______________________
PRODUCT
Celsite ST 301 P Implantable
Port Catheter. The device is a 6.5F
polyurethane implantable catheter.
The catheter is primarily used for
sub-clavian implantation. Recall
# Z-1223-2.
CODE
Product Codes CVS200KP and CVS250KP.
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical,
Inc., Allentown, PA, by letter on
October 25 and December 17, 2001.
Manufacturer: Braun, Aesculap, France.
Firm initiated recall is ongoing.
REASON
Fractures.
VOLUME OF PRODUCT IN COMMERCE
141 units.
DISTRIBUTION
AL, CA, FL, MD, NM, VA, and WA.
_______________________
PRODUCT
XT75410 Opti-Plast XT PTA Balloon Dilation Catheter;
XT100410 Opti-Plast XT PTA Balloon Dilation Catheter;
XT120410 Opti-Plast XT PTA Balloon Dilation Catheter
Recall # Z-1224-2.
CODE
Not lot specific.
RECALLING FIRM/MANUFACTURER
C. R. Bard, Inc./Bard Peripheral Technologies, Covington, GA, by telephone on June 10, 2002. Firm initiated recall is ongoing.
REASON
Product was distributed without 510(k) clearance.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
LA, OK and TN.
_______________________
PRODUCT
Streptozyme, Hemagglutination
slide test. Recall # Z-1225-2.
CODE
Product Code: 45D4
Lot Number 0224501 Exp. 6/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wample Laboratories,
Div. of Medpointe Healthcare, Inc.,
Cranbury, NJ, by letters on April
25, 2002.
Manufacturer: J&S Medical Associates,
Inc., Framingham, MA.
Firm initiated recall is ongoing.
REASON
Weak sensitivity, may result in weak
positives going undetected.
VOLUME OF PRODUCT IN COMMERCE
74.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Dimension(R) Xpand software revision
6.0.1 and 6.1 (Clinical Chemistry
Analyzer). Recall # Z-1226-2.
CODE
Xpand software revision 6.0.1 and
6.1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc.,
Newark, DE, by telephone on May 11,
2002.
Manufacturer: Dade Behring, Inc.,
Brookfield, CT.
Firm initiated recall is ongoing.
REASON
The sample probe does not accurately
track the fluid level.
VOLUME OF PRODUCT IN COMMERCE
261.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
TwistOR Bone Cement Mixer. Recall
# Z-1228-2.
CODE
Catalog No. CM-MD-3100
Lot No. AA0131 Exp. Date July 2002.
RECALLING FIRM/MANUFACTURER
Immedica, Inc., Chatham, NJ, by letters
on March 12 and 14, 2002.
Firm initiated recall is complete.
REASON
Non sterile box sent to hospital.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CT and IL.
_______________________
PRODUCT
Fabius Anesthesia Machine. The
device is exported only in accordance
with FFDCA section 801(e)(1). Recall
# Z-1229-2.
CODE
Catalog number 4115300.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Drager Medizintechnik
Gmbh Luebeck, by letter June 20,
2002.
Manufacturer: Drager Medical, Telford,
PA. Firm initiated recall is ongoing.
REASON
Ground wire too short.
VOLUME OF PRODUCT IN COMMERCE
1879 units.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Softchrome brand In-Office Tint
System, Complete System
Recall # Z-1232-2.
CODE
All codes, including (Red dye lot
nos. F0122, B0002;
Brown dye lot nos. L9916, B0027,
D0130).
RECALLING FIRM/MANUFACTURER
Softchrome, Inc., San Ramon, CA,
by letters dated May 2, 2002.
FDA initiated recall is complete.
REASON
Devices use unlisted dyes used in
a tinting kit for contact lenses.
VOLUME OF PRODUCT IN COMMERCE
123 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
Bio-Rad Chlamydia Blocking Assay.
Recall # Z-1217-2;
Bio-Rad Chlamydia Microplate EIA
- 96 Tests. Recall # Z-1218-2;
Bio-Rad Chlamydia Microplate EIA
- 192 Tests. Recall # Z-1219-2.
CODE
Lot #s 909468, 910235, 912578, 909681,
906620, 912400,
910620, 912579, 911794, 909469, 910236.
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Redmond, WA,
by letter dated January 15, 2002.
Firm initiated recall is complete.
REASON
Incorrect product information regarding
discarding out of range control.
VOLUME OF PRODUCT IN COMMERCE
2095.
DISTRIBUTION
Nationwide and Germany, Italy, France
and Portugal.
_______________________
PRODUCT
Acid Concentrate for Bicarbonate Dialysate AC-2403-4 Manufactured For Gambro Use with Gambro BP-002 Bicarbonate products. One Gallon. Recall # Z-1220-2.
CODE
Lot G0G084.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Healthcare, Daytona Beach, FL, by telephone beginning on September 13, 2002.
Manufacturer: Di-Chem Concentrates, Inc., Lewisberry, PA.
Firm initiated recall is complete.
REASON
Incorrect expiration date of 4/00.
VOLUME OF PRODUCT IN COMMERCE
1,150 cases.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Kallestad Anti-La (SSB) Microplate
EIA Kit labeled in part "Kallestad
Anti-La (SS-B) EIA ** Sanofi Diagnostics
Pasteur ** Chaska, MN **". Recall
# Z-1222-2.
CODE
Lot #192, expiration 10/12/01.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Rad Laboratoaries,
Redmond, WA, by letter dated February
1, 2001.
Manufacturer: Axis-Shield Diagnostics,
Ltd., Dundee, Scotland, United Kingdom.
Firm initiated recall is complete.
REASON
Ratio range on label of positive
control instead of concentration
range.
VOLUME OF PRODUCT IN COMMERCE
27.
DISTRIBUTION
FL, OH, TN, TX, WA, and WI.
_______________________
PRODUCT
501-1 One Sheet 12" x 12" x .015 Sil-Tec Sheeting a Class VI USP Medical Grade Silicone Rubber Latex-Free Reinforced and 501-3 One Sheet 12" x 12" x .020 Sil-Tec Sheeting a Class VI USP Medical Grade Silicone Rubber Latex-Free Reinforced. Recall # Z-1230-2.
CODE
Lot 1-041189.
RECALLING FIRM/MANUFACTURER
Technical Products, Inc. of Georgia, USA, Decatur, GA, by telephone on September 20, May 13 and 21, 2002 and by fax on June 7 and 11. 2002. Firm initiated recall is complete.
REASON
Product labeled Reinforced was not reinforced.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
CO, IL, NM, TX and UT.
_______________________
PRODUCT
Niagara TRS Thermal Retention
System, 2 Liter, Catalog No. 008075-901.
Recall # Z-1231-2.
CODE
Serial Numbers N02A023, N02A024,
N02A025, N02A026, and N02A027.
RECALLING FIRM/MANUFACTURER
ACMI Corporation, Racine, WI, by
letter on May 9, 2002.
Firm initiated recall is ongoing.
REASON
The product is a 2 liter system but
is misidentified on the device label
as a 3 liter system. This might result
in the user attempting to use a 3
liter fluid bag in the 2 liter system.
VOLUME OF PRODUCT IN COMMERCE
5 divices.
DISTRIBUTION
SD, MO, LA and WI.
_______________________
PRODUCT
Brand Name: ADVIA Centaur(R)
Analyzer. Recall # Z-1233-2.
CODE
All serial numbers distributed with
Model/Part Number 572561, along with
all existing software versions from
2.1 to 2.5.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Corporation,
Business Group Diagnostics, Tarrytown,
NY, by letter on March 13, 2002.
Manufacturer: Bayer Diagnostics Manufacturing
Limited, Swords County, Dublin. Firm
initiated recall is ongoing.
REASON
Software programming error.
VOLUME OF PRODUCT IN COMMERCE
2275 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
Dionne Medicated Udder Balm with
Lanolin and Aloe Vera Gel, packaged
in a 1-lb. jar, contains 0.25% menthol,
OTC, aids in the prevention of the
effects of frost and used for the
temporary relief of pain and itching
associated with minor cuts, scrapes,
and minor skin irritations. The responsible
firm on the label shows the product
is distributed by Dionne Products,
Des Moines, IA. Recall # V-155-2.
CODE
2A14C, Exp. January, 2004.
RECALLING FIRM/MANUFACTURER
Qualis, Inc., Des Moines, IA, by
telephone on May 31, 2002.
Firm initiated recall is complete.
REASON
Above specification for menthol.
VOLUME OF PRODUCT IN COMMERCE
72 jars.
DISTRIBUTION
IN and OK.
END OF ENFORCEMENT REPORT FOR AUGUST 21, 2002
####
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