FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and
Drug Administration,
U.S. Public Health Service, Department of Health and Human
Services. It contains information
on actions taken in connection with agency regulatory
activities.
December 24, 1997 97-52
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Sugar Free Peanut Butter Filled Milk Santa,
2 ounces. Recall #F-211-8.
CODE Lot #7274.
MANUFACTURER Gertrude Hawk Chocolates, Dunmore,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on October 20,
1997, followed by letter dated October 24,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 3,211 individual pieces of product were
distributed.
REASON Product contains undeclared peanut butters.
_______________
PRODUCT Cream Cheese and Tuna Salads in 8 ounce
plastic containers:
a) Rite brand Cream Cheese with Caviar
b) Chef Willey's Fancy Tuna Salad
Mediterranean Style with Roasted Garlic
c) Chef Willey's Fancy Tuna Salad with Fresh
Jalapeno. Recall #F-212/214-8.
CODE a) Date coded "NOV 16 1997"
b) Date coded "NOV 03 1997"
c) Date coded "NOV 10 1997".
MANUFACTURER Rite Foods, Inc., Boston, Massachusetts.
RECALLED BY Manufacturer, by press release and by fax on
November 14, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Massachusetts, Rhode Island, Connecticut,
Maine, New Hampshire, Vermont, New York,
New Jersey.
QUANTITY Firm estimates none remains on the market.
REASON Product may be contaminated with Listeria.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Dietary Supplements:
a) Theradex M dietary supplement under the
Therapeutic M brand
b) Stress with Iron dietary supplement
c) Coach's Formula dietary supplement
d) Ultra 50 Revised dietary supplement under
the Super Multiple 50 brand
e) Vitamin / Mineral Tablet dietary
Supplement. Recall #F-195/199-8.
CODE Lot numbers: a) 047155 and 047156
b) 047110; c) coded 057067
d) 037027, 037028, 037025, 047089, 047090,
047091; e) coded 057024.
MANUFACTURER Manhattan Drug Company, Hillside, New Jersey.
RECALLED BY Manufacturer, by letter on July 17, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey and New York.
QUANTITY a) 1,923,600 130-tablet bottles; b) 983,000
tablets; c) 474,700 tablets;
d) Lot 037027 - 624,200 tablets
Lot 037028 - 615,400 tablets
Lot 037025 - 619,100 tablets
Lot 047089 - 593,400 tablets
Lot 047090 - 622,600 tablets
Lot 047091 - 631,400 tablets;
e) 494,200 caplets were distributed.
REASON Products contain excessive levels of lead.
_______________
PRODUCT Children's Chewable Vitamins:
a) Selectives 2000 TM Dietary Supplement,
Children's Chewables 60 Tablets per bottle.
Distributed by Stanley Home Products.
b) Dawn Pharmaceuticals Children's Chewable
Multiple Vitamins with Iron (Animal Shape),
-2-
100 Tablets per bottle, Distributed by Dawn
Pharmaceuticals. NDC: 58865-0011-01.
Recall #F-200/201-8.
CODE a) Lot # 047039; b) Lot #057003.
MANUFACTURER ADH Health Product, Inc., Congers, New York.
RECALLED BY Manufacturer, by letters dated July 8, 19, or
23 1997. Firm-initiated recall ongoing.
DISTRIBUTION a) Kansas; b) New York and Illinois.
QUANTITY a) 2,192 bottles; b) 336 bottles were
distributed.
REASON The products contain excessive levels of
lead.
_______________
PRODUCT Windmill Farms brand bakery products packaged
in clear, colorless plastic bags:
a) Sour Dough Spelt Rolls (with raisins), net
wt. 15 oz.
b) Sour Dough Rye & Spelt, net wt. 24 oz. (1
lb. 8 oz.)
c) Sour Dough Spelt Challa Rolls, net wt. 15
oz.
d) Sour Dough Spelt, net wt. 24 oz. (1 lb. 8
oz.)
e) Multi-Grain Sour Dough Spelt, net wt. 20
oz.(1 lb. 4 oz.)
f) Honey Spelt, net wt. 18 oz. (1 lb.2 oz.)
g) Real Jewish Rye, net wt. 18 oz. (1 lb. 2
oz.)
i) Whole Spelt Challah, net wt. 15 oz.
j) Whole Spelt Challah Roll, net wt. 15 oz.
Recall #F-202/210-8.
CODE All products labeled as "wheat free".
MANUFACTURER The Bread Board, Inc., doing business as
Windmill Farms, Brooklyn, New York.
RECALLED BY Manufacturer, by revising the labels and
removing all improperly labeled "Wheat Free"
bread products from retail shelves by October
31, 1997. Completed recall resulted from
sample analysis and followup by the New York
State Department of Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY Firm estimates none remains on the market.
REASON These products contain spelt, a type of wheat,
and are labeled as "wheat free" which can pose
a hazard to individuals sensitive to wheat.
_______________
UPDATE This update replaces in entirety the listing
of recall numbers F-139/185-8 which appeared
in the December 10, 1997 Enforcement Report.
For products listed under F-144-8 through
-3-
F-170-8, it should be noted that with FDA
concurrence, some of these lots have been
further tested and found acceptable for
redistribution:
F-139-8 I Can't Believe It's Not Butter!
Squeeze in 16 oz. bottles (packed 18 per case,
SKU 346000) coded DEC1697A
F-140-8 I Can't Believe It's Not Butter! Soft
1 lb. tubs (packed 24 per case, SKU 354024)
coded DEC1597A, DEC1697A, and DEC1797A; 3 lb.
tubs (packed 6 per case, SKU 390120)
coded DEC1797A
F-141-8 I Can't Believe It's Not Butter! 1 lb.
quarters (packed 30 to a case, SKU 341180)
coded DEC1597A, DEC1697A, and DEC1797A
F-142-8 Country Crock Churnstyle Soft 3 lb.
tubs (packed 12 to a case, SKU 392120) coded
DEC1797A and DEC1897A
F-143-8 Country Crock Lite 3 lb. tubs (packed
12 to a case, SKU 522701) coded NOV2697A and
DEC1897A
F-144-8 Country Crock Soft 5 lb. tubs (packed
6 to a case, SKU 514006) coded DEC1597A; 3 lb.
tubs (packed 12 per case, SKU 503012) coded
DEC1697A, DEC1797A, and DEC1897A; 1 1/2 lb.
tubs (packed 12 to a case, SKU 513012) coded
DEC1797A and DEC1897A; 1 lb. tubs (packed 24
to a case, SKU 511024) coded DEC1597A,
DEC1697A, DEC1797A, and DEC1897A
F-145-8 Country Crock & Honey 14 gm (packed
432 count, 13.3 lb. cases, SKU 250751) coded
A7169 and A7170
F-146-8 Country Crock 5 gm (packed 900 count,
10 lb. cases, SKU 250811) coded A7169 and
A7170
F-147-8 Country Crock Classic 1 lb. quarters
(packed 30 to a case, SKU 515030) coded
DEC1797A and DEC1897A
F-148-8 Country Crock Churnstyle 1 lb.
quarters (packed 30 to a case, SKU 392000)
coded DEC1897A
F-149-8 Kroger 3 lb. tubs (packed 6 per case,
SKU 730899) coded DEC1697A and DEC1797A
F-150-8 Imperial Delight Soft 3 lb. tubs
(packed 6 per case, SKU 566206) coded DEC1697A
F-151-8 Wilson 8 oz. mugs (packed 36 per case,
SKU 731069) coded DEC1597A
F-152-8 Wilson Spread 3 lb. tubs (packed 6 per
case, SKU 731067) coded DEC1697A
F-153-8 Filbert 8 oz. mugs (packed 36 per
case, SKU 043000) coded DEC1597A
-4-
F-154-8 Filbert Family Spread 3 lb. tubs
(packed 6 per case, SKU 080000) coded DEC1797A
F-155-8 Filbert 1 lb. quarters (packed 30 per
case, SKU 001300) coded DEC1797A and DEC1897A
F-156-8 Sysco Farm Fresh 5 gm (packed 900
count, 10 lb. cases, SKU 980502) coded A7169,
A7170, A7171, and A7172; 14 gm (packed 432
count, 13.3 lb. cases, SKU 980523) coded
A7170, A7171
F-157-8 Promise 5 gm (packed 600 count, 10 lb.
cases, SKU 730614) coded A7170, A7171, and
A7172
F-158-8 Our Family Soft 3 lb. tubs (packed 6
per case, SKU 730484) coded DEC1697A
F-159-8 Morning Fresh Spread 3 lb. tubs
(packed 6 per case, SKU 730059) coded DEC1697A
F-160-8 Hy Top Spread 3 lb. tubs (packed 6 per
case, SKU 730396) coded DEC1697A and DEC1797A
F-161-8 Shedd's 6 oz. mugs (packed 36 per
case, SKU 504020) coded DEC1697A
F-162-8 Shedd's Spread 1 lb. quarters (packed
30 per case, SKU 512030) coded DEC1697A and
DEC1797A
F-163-8 Shedd's Garlic Spread 1 lb. tubs
(packed 12 per case, SKU 731131) coded
DEC1797A
F-164-8 Publix Spread 3 lb. tubs (packed 6 per
case, SKU 730914) coded DEC1697A and DEC1897A
F-165-8 Janet Lee Spread 3 lb. tubs (packed 6
per case, SKU 730418) coded DEC1697A and
DEC1797A
F-166-8 Better Value Spread 1 lb. quarters
(packed 30 per case, SKU 730057) coded
DEC1697A
F-167-8 Pizza Hut Garlic Spread 1 lb. tubs
(packed 12 per case, SKU 730605) coded
DEC1897A
F-168-8 Great Value 2 lb. tubs (packed 12 per
case, SKU 870316) coded DEC1897A
F-169-8 Great Value Spread 3 lb. tubs (packed
6 per case, SKU 870315) coded DEC1897A
F-170-8 Morning Fresh Spread 3 lb. tubs
(packed 6 per case, SKU 730059) coded DEC1897A
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Glucophage Metformin HCl Tablets, 500 mg, in
bottles of 180 tablets, Rx oral
antihyperglycemic. NDC#0339-6022-14.
Recall #D-042-8.
CODE Lot #LN041021 EXP 06/30/98.
-5-
MANUFACTURER Bristol Laboratories Corporation, a Bristol-
Myers Squibb Company, Mayaguez, Puerto Rico.
RECALLED BY Caremark, Inc., Prescription Services
Division, Northbrook, Illinois, on
November 13, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Texas, Illinois, Virginia.
QUANTITY 1,066 bottles were distributed; firm estimates
that little, if any of the lot remains on the
market.
REASON Tablet mix-up - At least one bottle was found
to contain Relafen Nabumetone Tablets, 500 mg
(nonsteriodal anti-inflammatory-white oval
tablets).
_______________
PRODUCT Benztropine Mesylate, 2 mg Tablets, Rx, in
unit dose blister strips of 30, 60, 90, 250,
or 500 units, under the Heartland Healthcare
label. Recall #D-048-8.
CODE Lot #01601A EXP 8/19/97.
MANUFACTURER Heartland Healthcare Services, Toledo, Ohio
(repacker/relabeler/responsible firm).
RECALLED BY Repacker, by letter dated November 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio, Kentucky, Florida, Illinois,
West Virginia.
QUANTITY 76 unit dose packed blister strips
(10,560 tablets) were distributed.
REASON Mislabeling - Some units are labeled as
containing Atenolol 50 mg tablets.
_______________
PRODUCT Propranolol HCl LA Capsules, 60 mg, in single
dose packets of 10 blister strips, Rx
medication for the management of hypertension.
NDC #59911-5470-1. Recall #D-053-8.
CODE Lot #9970632 EXP 5/99.
MANUFACTURER ESI-Pharma, Inc., Philadelphia, Pennsylvania.
RECALLED BY AmeriSource Corporation, Louisville, Kentucky,
by telephone on December 2, 1997, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 99 unit dose packets were distributed.
REASON Mislabeling - Product lacked the LA (long
acting) indication.
_______________
PRODUCT Theocron Tablets (Theophylline Anhydrous,
USP), Extended-Release, 200 mg, in 100 count
unit dose strips, Rx. NDC #0182-1590-89.
Recall #D-054-8.
-6-
CODE Lot numbers: 42H7473 and 42H7474.
MANUFACTURER Ivax Company, Quebec, Canada
(repacker/responsible firm).
RECALLED BY Zenith Goldline Pharmaceuticals, Fort
Lauderdale, Florida, by letter on November 26,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,723 unit dos boxes of 100 were distributed.
REASON Mislabeling - Labeling fails to bear the
extended-release statement.
_______________
PRODUCT OXY 10 Medicated Face Wash (10% Benzyl
Peroxide), in 8 fluid ounce plastic bottles,
OTC, intended for young adults who regularly
have pimples and oily skin. Recall #D-055-8.
CODE Lot #7F25 EXP 6/99.
MANUFACTURER SmithKline Beecham Consumer Healthcare, L.P.,
St. Louis, Missouri.
RECALLED BY SmithKline Beecham Consumer Healthcare, L.P.,
Parsippany, New Jersey, by telephone on August
19, 1997, and by letters on August 22 and 29,
1997, and September 9, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 152 cases were distributed.
REASON Product contaminated with Burkholderia
cepacia.
_______________
UPDATE The Victor Medical (St. Louis, MO) recall of
Oxygen USP, in aluminum high pressure
cylinders, M-6, M-7, and M-9 Cylinders, Recall
#D-032-8, which appeared in the November 12,
1997 Enforcement Report has been extended to
include Valve date (Victor) coded as VBD, VCD,
VDD or VED.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Ferotrinsic Capsules (Hematinic Concentrate
with Intrinsic Factor), in 100 tablet bottles,
a prescription vitamin. Recall #D-040-8.
CODE Lot numbers 071437 and 072007.
MANUFACTURER Rugby Laboratories, Inc., Norcross, Georgia.
RECALLED BY Manufacturer, by letter on September 3, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates 9,399 bottles remain in
commerce.
-7-
REASON Mislabeling - Product bears the wrong strength
for iron (as ferrous fumarate) labeled as 10
mg, but actually contains 110 mg per capsule.
_______________
PRODUCT Vivelle(tm) Patches (Estradiol Transdermal
System), 0.075 mg/day, a patch system therapy
for estrogen replacement in postmenopausal
women. Recall #D-041-8.
CODE Lot #6B1219A1 EXP 3/98.
MANUFACTURER Noven Pharmaceuticals, Inc., Miami, Florida.
RECALLED BY Novartis Pharmaceutical Corporation (formerly
Ciba-Geigy), Suffern, New York, by telephone
on October 22, 1997, and by letter on November
6, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,214 cartons (8 pouches/packet per carton)
were distributed.
REASON Mislabeling - Product distributed bearing
physician sample-not for sale labeling.
_______________
PRODUCT Hydra-Zide Capsules (Hydralazine HCl and
Hydrochlorothiazide), 25 mg/25mg, in bottles
of 100, Rx used for the treatment of
hypertension, under the following labels:
Par Pharmaceutical Inc. (NDC 49884-143-01)
Martec Pharmaceutical, Inc. (NDC 52555-143-01)
Major Pharmaceuticals (NDC 0904-2855-60)
Qualitest Pharmaceuticals, Inc.
(NDC 0603-3834-21)
United Research Laboratories, Inc.
(NDC 0677-0773-01). Recall #D-043-8.
CODE Lot numbers: 006675, 007194, 007272, 007302,
007492, 008022, 008023, 008124. All lots
expire on May 1999.
MANUFACTURER Par Pharmaceutical, Inc., Spring Valley,
New York.
RECALLED BY Manufacturer, by letter mailed on November 10,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,633 bottles were distributed.
REASON Superpotent for Hydrochlorothiazide (three
month stability test station).
_______________
PRODUCT Demadex Tablets (Torsemide), 5 mg, 10 mg,
20 mg, 100 mg, in bottles of 100, used for
the indication of edema. NDC #53169-104-01.
Recall #D-044/047-8.
CODE All lots.
MANUFACTURER Boehringer Mannheim GmbH, Mannheim, Germany.
RECALLED BY Boehringer Mannheim Corporation Therapeutics
(BMCT), Gaithersburg, Maryland, by letter sent
by fax on November 11, 1997, and by mail on
November 12, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,880 bottles were distributed.
REASON Labeling - Some bottles do not have a
complete printing of the lot number and/or
expiration date.
_______________
PRODUCT VHA Plus Dobutamine brand Dobutamine
Hydrochloride Injection, 250 mg, in 20 mL
single dose vials, Rx, a direct acting
inotropic agent. NDC #0002-7375-01 and
0002-7375-10. Recall #D-049-8.
CODE Lots: 0ND89S, EXP Feb 1, 1999; 0NC01M, EXP
Feb 1, 1999; 0NE84M, EXP Mar 1, 1999; 1MF86N,
EXP April 1, 1999; 1MH14N EXP May 1, 1999;
1MK15M, EXP June 1, 1999; 1ML66N, EXP June 1,
1999; 1MR42M, EXP July 1, 1999; 1MS84N EXP Aug
1, 1999; 1MS57M EXP Aug 1, 1999; 1MU20M, EXP
Sept 1, 1999.
MANUFACTURER Eli Lilly and Company, Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter November 7, 1997, and
by telephone on November 10, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1.8 million vials were
distributed.
REASON Mislabeling - Some immediate container labels
are missing the "2" from 20 ml in their
strength indication statement - Equiv to 250
mg Dobutamine per 20 ml.
_______________
PRODUCT Hemorrhoidal Suppositories (phenylephrine HCl
0.25% Zinc oxide 11%), in 12, 24, and/or 30
units per package, OTC product under the
following labels: Eckerd Drug, FDC Wholesale,
Genovese Drug Stores, Super G, G & W,
Federated Group, McCrory Stres, Navarro
Discount Pharmacies, Nash Finch, Federated
Foods, Revco D.S., Select Brand Distributors,
Venture Stores, CVS, Discount Drug Mart, Fedco
Professional Pharmacies, Family Pharmacy,
Bindley Western/First Choice, Drug Emporium.
-8-
NDC numbers: 19458-7011-1, 59085-302-12, 0713-0505-12,
43083-505-10, 52735-715-05, 0713-0505-24.
Recall #D-051-8.
CODE Lot Numbers and EXP dates:
5293-1 5/97, 5293-2 5/97; 5293-3 5/97
5293-4 5/97; 5321-7 6/97; 5321-8 6/97
5321-9 6/97; 5322-1 6/97; 5322-2 6/97
5322-3 6/97; 5322-4 6/97; 6111-5 11/97
6169-1 1/98; 6180-1 1/98; 6199-1 1/98;
6199-2 1/98; 6216-9 2/98; 6217-1 2/98;
6230-3 3/98; 6261-9 4/98; 6269-1 4/98;
6285-1 4/98; 6291-2 5/98; 6325-2 6/98;
6345-1 6/98; 6353-8 7/98; 6353-9 7/98;
6366-5 7/98.
MANUFACTURER G & W Laboratories, Inc., South Plainfield,
New Jersey.
RECALLED BY Manufacturer, by letter sent on May 13, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 409,805 packages of product were distributed.
REASON Subpotent; Phenylephrine HCl.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-039-8.
CODE Unit numbers: 50G23524, 50H72174, 50H56731.
MANUFACTURER American Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by letter dated July 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois, Michigan, Ohio.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor who
traveled to a malarial endemic area.
_______________
PRODUCT Red Blood Cells. Recall #B-079-8.
CODE Unit #12423-7241.
MANUFACTURER United Blood Systems, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated July 11, 1997. Firm-initiated
recall complete.
DISTRIBUTION New Mexico.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to a malarial endemic area.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Fresh Frozen Plasma
d) Cryoprecipitated AHF; e) Recovered Plasma
Recall #B-158/162-8.
-9-
CODE Unit numbers: a) 29095-7127, 29094-0731
b) 29094-0731; c) 29094-0731
d) 29095-7127; e) 29095-7127.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated September 8, 1997, and by fax on
September 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY a) 2 units; b-e) 1 unit of each component was
distributed.
REASON Blood products were collected from a donor who
had been deferred for a previous blood
exposure.
_______________
PRODUCT LifeTec Community Blood Center System Computer
Software, Revision 2.00. Recall #B-285-8.
CODE LifeTec Revision 2.00 and User Manuals for the
software; User Manual: Sec II, Laboratory and
Component Processing, Page II 3.2.2 dated
3/1/96.
MANUFACTURER Systec Computer Associates, Inc., Mt. Sinai,
New York.
RECALLED BY Manufacturer, by memorandum on April 2, 1997,
by fax on October 27, 1997, and additional
memorandum on October 28, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Georgia, Iowa, Louisiana, Mississippi, South
Carolina, Tennessee.
QUANTITY 7 donor centers received software and manuals.
REASON Computer software did not perform as stated in
the product's labeling.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-345/346-8.
CODE Unit #V32910.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated October 9 or 14,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois and Indiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT Platelets. Recall #B-362-8.
CODE Unit #O3KC06584.
-10-
MANUFACTURER American Red Cross Blood Services, Miami,
Florida.
RECALLED BY Manufacturer, by telephone on September 15,
1997. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product contained an insufficient amount
of plasma.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-371/372-8.
CODE Unit numbers: 10500-8925, 10496-3333.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated October 28, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois, New Mexico, Switzerland.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor
who had ear piercing within 12 months of
donation.
_______________
PRODUCT Source Plasma. Recall #B-376-8.
CODE Unit numbers: FT11006586, FT11006548,
FT11006467, FT11006447, FT11006449,
FT11006366, FT11006315.
MANUFACTURER Serologicals, Inc., Clarkston, Georgia.
RECALLED BY Manufacturer, by fax on June 25, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Federal Republic of Germany.
QUANTITY 7 units were distributed.
REASON Blood products tested negative for the
antibody to Hepatitis B Surface antigen
(anti-HBsAg), but collected from a donor who
previously tested repeat reactive for
anti-HBsAg, non-neutralizable and anti-HBc
negative.
_______________
PRODUCT Red Blood Cells. Recall #B-379-8.
CODE Unit #28LE18325.
MANUFACTURER American Red Cross, Savannah, Georgia.
RECALLED BY Manufacturer, by telephone on July 16, 1997,
and by letter dated July 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
traveled to a malarial endemic area.
-11-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-250-8.
CODE Unit #03GP15660.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on September 3,
1997. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood with an extended collection time.
_______________
PRODUCT Platelets. Recall #B-251-8.
CODE Unit numbers: 9031412 9038784 9038787
9036006 9037928 9037929 9037930 9037934
9037932 9039172 9039177 9039179 9039173.
MANUFACTURER Florida Blood Services, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by telephone followed by fax on
November 5 and 6, 1996. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 13 units were distributed.
REASON Blood products were incorrectly tested for
syphilis.
_______________
PRODUCT a) Red Blood Cells; b) Whole Blood Cells;
c) Platelets. Recall #B-318/320-8.
CODE a) Contact FDA, Center for Biologics
Evaluation and Research, Office of Compliance
(301) 827-6220 for individual unit numbers
recalled; b) G34393, J00845, J00883, J02464,
J02512, J03157, J04533, J05461, J05613,
J08668, J08704, J08765, KC72792, KC78284,
KC90843, KC90961, KC94340, W27086, W27209;
c) LP04830, LP04844, P18365, P18749, LP04788, and
P18991.
MANUFACTURER Lifeblood/Mid-South Regional Blood Center,
Memphis, Tennessee.
RECALLED BY Manufacturer, by letter mailed on January 6,
1997, or February 14, 1996. Firm-initiated
recall complete.
DISTRIBUTION Alabama, Arkansas, Maryland, Mississippi,
Missouri.
QUANTITY a) 122 units; b) 19 units; c) 6 units.
REASON Unlicensed blood products were distributed in
interstate commerce.
-12-
_______________
PRODUCT Red Blood Cells. Recall #B-324-8.
CODE Unit #21365-9160.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on July 5, 1997. Firm-initiated
recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Source Plasma. Recall #B-327-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 827-6220
for individual unit numbers recalled.
MANUFACTURER North American Biologicals, Inc., Lexington,
Kentucky.
RECALLED BY Manufacturer, by letter dated August 5, 1997,
or September 18, 1997. Firm-initiated recall
complete.
DISTRIBUTION New York, North Carolina, New Jersey, France.
QUANTITY 536 units were distributed.
REASON Source plasma was exposed to unacceptable
storage temperatures and not relabeled as
source Plasma, Salvaged.
_______________
PRODUCT Red Blood Cells. Recall #B-338-7.
CODE Unit numbers: 21364-9885, 21364-9983.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated June 23, 1997, and September 5,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units were distributed.
REASON Blood products were not refrigerated within
eight hours of collection.
_______________
PRODUCT Red Blood Cells. Recall #B-339-8.
CODE Unit #21360-6215.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated April 8, 1996. Firm-initiated
recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at an unacceptable
temperature.
-13-
_______________
PRODUCT Red Blood Cells, Leukocytes Reduced,
Irradiated. Recall #B-340-8.
CODE Unit #21GL29693.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated September 15,
1997. Firm-initiated recall complete.
DISTRIBUTED Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was leukodepletled greater than
seven days after collection.
_______________
PRODUCT Red Blood Cells. Recall #B-344-8.
CODE Unit #5127888.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on June 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product had an acceptable ALT, but was
collected from a donor who previously had an
elevated ALT on two separate occasions.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-363-8.
CODE Unit numbers: 21362-2344, 21362-2347,
21362-2348, 21362-2349, 21362-2350,
21362-2351, 21362-2352, 21362-2354,
21362-2356, 21362-2357, 21362-2358,
21362-2359, 21362-2360.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on September 20, 1996. Firm-
initiated recall complete.
DISTRIBUTION North Dakota and South Dakota.
QUANTITY 13 units were distributed.
REASON Unlicensed blood products were distributed,
labeled with the firm's license number.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-364/365-8.
CODE Unit #10506-0823.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated April 29, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for viral
markers and had an acceptable ALT, but were
collected from a donor who previously had an
-14-
elevated ALT on two separate occasions.
_______________
PRODUCT a) Red Blood Cells
b) Red Blood Cells-Leukocytes removed
c) Cryoprecipitated AHF
d) Recovered Plasma. Recall #B-367/370-8.
CODE Unit numbers: a) 19033-1104; b) 19032-3971
c) 19032-3971; d) 19032-3971, 19033-1104.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
letter on September 18, 1997. Firm-initiated
recall complete.
DISTRIBUTION Alaska, Nevada, North Carolina, Switzerland.
QUANTITY a) 1 unit; b) 1 unit; c) 1 unit; d) 2 units
were distributed.
REASON Blood products had an acceptable ALT, but were
collected from a donor who previously had an
elevated ALT on two separate occasions.
_______________
PRODUCT a) Red Blood Cells; b) Platelets, for further
manufacturing; c) Recovered Plasma.
Recall #B-373/375-8.
CODE Unit #16047-7392.
MANUFACTURER United Blood Services, Meridian, Mississippi.
RECALLED BY Blood Services, Inc., Scottsdale, Arizona,
by letters on September 24, 1997, and November
10, 1997. Firm-initiated recall complete.
DISTRIBUTION Mississippi, New York, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had an acceptable ALT, but were
collected from a donor who previously had an
elevated ALT on two separate occasions.
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF.
Recall #B-377/378-8.
CODE Unit numbers: a) 21360-0424, 21360-0823,
21360-1051, 21360-1056, 21360-1087,
21360-1107, 21360-1119, 21360-1205,
21360-1211, 21360-1236, 21360-1243,
21360-1260, 21360-1492, 21360-1625,
21360-1634, 21360-1649, 21360-1785,
21360-1849, 21360-1894, 21360-1944,
21360-1964, 21360-1987, 21360-2213,
21360-2307, 21360-2439, 21360-2452,
21360-2469, 21360-1976.
b) 21360-1068, 21360-1260, 21360-1625,
21360-1649, 21360-2204.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on January 9, 1996. Firm-initiated
-15-
recall complete.
DISTRIBUTION Illinois, Minnesota, North Dakota,
South Dakota, Texas, Nevada.
QUANTITY a) 28 units; b) 5 units were distributed.
REASON Blood products which were tested for the
antibody to the hepatitis B core antigen
(anti-HBc), using an automatic pipettor that
failed volume verification.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Direct Power Transformers:
a) Transformer Model #75210. This transformer
is a plug in power supply that powers the
Domestic LumiView (110 volt version). The
LumiView is a portable binocular microscope
used to view the ear, nose, throat and other
small cavities. The plug-in transformer is
sold as an accessory for the LumiView.
This device is also included in sets
identified below:
b) Product No. 20510H Headband LumiView with
Direct Plug Power;
c) Product No. 20510HV (Same as 20510H -
Labeled For Veterinary Use);
d) Product No. 20510S Spectacle LumiView with
Direct Plug-In; and
e) Product No. 20510SV (Same as 20510S -
Labeled For Veterinary Use).
Recall #Z-193/197-8.
CODE Date Code July 96 through December 96.
MANUFACTURER Sino-American Electronic Company, Ltd.,
Kaohsiung Hsien, Taiwan, R.O.C.
RECALLED BY Welch Allyn, Inc., Skaneateles Falls,
New York, by memorandum dated October 21,
1997, and by letter dated November 997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 810 units were distributed.
REASON The transformers secondary fuse was
incorrectly wired and therefore not
functional, compromising the safety of the
transformer that could result in a burn and/or
a shock hazard to anyone touching the
transformer under certain conditions.
_______________
PRODUCT Bard William Harvey H-130 Over Pressure Safety
Valve (OPS), used to prevent negative pressure
from building inside the ventricle during left
ventricular venting and to reduce the
-16-
possibility of pumping air or solution into
the left ventricle should positive pressure
build between the pump and the valve.
Recall #Z-212-8.
CODE H130 Standalone device:
Lot numbers: 43BHV119-43BHV140,
43CHV101-43CHV136, 43DHV101- 43DHV128,
43EHV101-43EHV120, 43FHV101-43FHV118,
43GHV101- 43GHV114, 43HHV101-43HHV117,
43IHV101-43IHV120.
Tube Packs (multiple components):
All Bard Vascular Systems tubing packs which
contain the OPS valves with lot numbers:
28GHX---, 28HHX---, 28JHX---. The---
represents any number 0 through 9.
** Recall Extended on 11/25/97 to include lot
numbers: 43EHX---, 43FHX---.
MANUFACTURER Bard, Las Piedras, Puerto Rico;
A.C. Hoffman Engineering, Riverside California
(valve vendor).
RECALLED BY Bard Vascular Systems Division, C.R. Bard
Inc., Haverhill, Massachusetts, by letter on
October 30, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Australia.
QUANTITY Approximately 67,000 units were distributed.
REASON Valve is occluded preventing blood flow
through valve.
_______________
PRODUCT Hamilton Disposable Precision Tips, used to
aspirate and dispense fluid:
a) Part #235300, box of 504 tips
b) Part #235400, case of 504 tips.
Recall #Z-227/228-8.
CODE Lot Numbers: a) 23397R, 33397R, 43397R,
53397R, 63397R, 73397R, 13497R, 23497R,
33497R, 43497R, 53497R, 63497R, 73497R,
13597R, 23597R, 33597R, 13697R, 23697R,
33697R, 53697R
b) 23397R, 33397R, 43397R, 53397R, 63397R,
73397R, 13497R, 23497R, 33497R, 43497R,
63497R, 73497R.
MANUFACTURER Tech Group Tempe, Tempe, Arizona.
RECALLED BY Hamilton Company, Reno, Nevada, by letter on
December 17, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 164 cases were distributed.
REASON The barrels of the tips were manufactured
using a non-antistatic polypropylene.
-17-
_______________
PRODUCT Autraumax Reusable Surgical Clamps, used
during cardiovascular, peripheral vascular,
and general surgery: a) Model A3312;
b) Model A3313; c) Model A3314; d) G-5020; e)
Model G-5028 ; d) Model G-5050; e) Model
G-5128; f) Model G-5040, g) Model G-5740.
Recall #Z-229/237-8.
CODE Lot numbers: a) E7H077; b) E7H075;
c) E7H076; d) E7F121; e) E7E077;
f) E7E003, E7E050, E7E049;
g) 97D138; h) RE7E04; i) R7D003.
MANUFACTURER Applied Medical Resources, Laguna Hills,
California.
RECALLED BY Manufacturer, by fax between October 10 and
13, 1997, followed by telephone between
October 13 and 20, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Australia, Israel, Japan,
The Netherlands.
QUANTITY 109 clamps were distributed.
REASON A fracture can occur near the jaw/male box
lock interface while the clamp is being placed
during surgery.
_______________
PRODUCT FibriJet Surgical Sealant Applicators, fibrin
sealant delivery systems used during surgery:
a) Model SA-4100 (1cc); b) SA-4305 (5 cc)
c) SA-4310 (10 cc). Recall #Z-239/241-8.
CODE Model SA-4100, all lot numbers below 12905
Model SA-4305, all lot numbers below 12908
Model SA-4310, all lot numbers below 12907.
MANUFACTURER Micromedics, Inc., Eagan, Minnesota.
RECALLED BY Manufacturer, by letter dated November 12,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,166 units were distributed.
REASON The sterile packaging of the products was
found to be weak and defective.
-18-
END OF ENFORCEMENT REPORT FOR DECEMBER 24, 1996. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
![[FDA HOME PAGE]](/icon/iconhome.gif)