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.
ENFORCE
04/24/1996
ENFORCEMENT REPORT FOR 04/24/96
April 24, 1996 96-17
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-442-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Cyril's Ice House and Supplies, Shell Beach,
Louisiana.
RECALLED BY Manufacturer, by telephone on February 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Mississippi, Alabama, Louisiana.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-443-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Motivatit Seafoods, Inc., Houma, Louisiana.
RECALLED BY Manufacturer, telephone on or about February
23, 1996. Firm had been notified by Louisiana
State on February 23, 1996. Firm-initiated
recall complete.
DISTRIBUTION California, Louisiana, Arizona, Maryland, New
York, New Jersey, North Carolina, Delaware,
Pennsylvania, Florida, South Carolina.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters and Shucked Oysters
Harvested at Drum Bay, Black Bay, Lake
Fortuna, Or Lake Machias, Louisiana.
Recall #F-444/445-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Tony V's Oysters, Inc., Amite, Louisiana.
RECALLED BY Manufacturer, by telephone on or about
February 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Louisiana, Alabama, Tennessee, Georgia.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias, LA.
Recall #F-446-6.
CODE Harvested between 1/23 and 2/23/96.
MANUFACTURER Melerine Seafood, Inc., St. Bernard,
Louisiana.
RECALLED BY Manufacturer, by telephone, on or about
February 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Mississippi, Louisiana, Alabama, South
Carolina.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-447-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Guidry's Seafood, Cutoff, Louisiana.
RECALLED BY Manufacturer, by telephone on February 26,
1996. Firm-initiated recall complete.
-2- DISTRIBUTION Texas and Louisiana.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shucked Oysters harvested at Drum Bay, Black
Bay, Lake Fortuna, or Lake Machias, Louisiana,
in 1 gallon plastic containers (7 pounds
each). Recall #F-448-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Louisiana Seafood Exchange, Jefferson,
Louisiana.
RECALLED BY Manufacturer, by telephone on or about
February 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Louisiana and Mississippi.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-449-6.
CODE Harvested 1/23 - 2/23/96.
MANUFACTURER Fox Seafood, Inc., Pointe-a-la-Hache,
Louisiana.
RECALLED BY Manufacturer. Firm was notified by the State
of Louisiana on February 23, 1996. Firm-
initiated recall complete.
DISTRIBUTION Georgia, Florida, Alabama.
QUANTITY Approximately 2,000 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shucked Oysters harvested at Drum Bay, Black
Bay, Lake Fortuna, or Lake Machias, Louisiana.
Recall #F-450-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Mr. Rabbit, Inc., Plaquemines, Louisiana.
-3- RECALLED BY Manufacturer, by visit completed on February
28, 1996. Firm had been contacted by the
State of Louisiana regarding the oyster
problem. Firm-initiated recall complete.
DISTRIBUTION Georgia, Louisiana.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-451-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Southern Foods Cajun Cuisine, Ycloskey,
Louisiana.
RECALLED BY Manufacturer, by telephone on February 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Virginia, North Carolina, Florida, Alabama,
Mississippi.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters and shucked oysters
harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, Louisiana. Recall
#F-452/453-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Taban's Seafood, River Ridge, Louisiana.
RECALLED BY Manufacturer, by telephone on or about
February 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Mississippi, Missouri, New York, Utah.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shucked Oysters harvested at Drum Bay, Black
Bay, Lake Fortuna, or Lake Machias, Louisiana,
in gallon plastic containers.
Recall #F-454-6.
CODE 1/27/96; 2/1/96; 2/7/96.
MANUFACTURER Pearson's Seafood, Inc., Lacombe, Louisiana.
-4- RECALLED BY Manufacturer, by telephone on or about
February 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 38 1-gallon containers were distributed.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between 1/23 -
2/23/96 have been associated with outbreaks of
gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-455-6.
CODE Harvest dates of 1/23 - 2/23/96.
MANUFACTURER Gulf Island Seafood, Hopedale, Louisiana.
RECALLED BY Manufacturer, by telephone and by letter
February 9, 1996. Firm had been contacted by
Louisiana State regarding oyster recall.
Firm-initiated recall complete.
DISTRIBUTION Louisiana, Virginia, Alabama, Maryland, North
Carolina.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shucked Oysters harvested at Black Bay.
Recall #F-456-6.
CODE Harvest date of 2/15/96.
MANUFACTURER Battistella's Seafood, New Orleans, Louisiana.
RECALLED BY Manufacturer, by telephone on or about
February 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 6 gallons were distributed.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters and halfshell oysters
harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, Louisiana.
Recall #F-457/458-6.
CODE Harvest dates of 1/23 - 2/23/96;
MANUFACTURER Pace Oysters and Seafood, Inc., Buras,
Louisiana.
-5- RECALLED BY Manufacturer, by telephone immediately
following notification from the State of
Louisiana on February 23, 1996. Firm-
initiated recall complete.
DISTRIBUTION Florida, North Carolina, Louisiana, New York,
Mississippi, Alabama.
QUANTITY Approximately 4,512 100-pound sacks of raw
shellstock oysters and 53 boxes of halfshell
oysters were distributed; firm estimates none
remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-459-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Lafrance Seafood, Inc., Pointe-a-la-Hache,
Louisiana.
RECALLED BY Manufacturer, by fax and by telephone on or
about February 23, 1996. Firm-initiated
recall complete.
DISTRIBUTION Virginia.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters and Shucked Oysters
harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, Louisiana.
Recall #F-460/461-6.
CODE Harvested between 1/23 - 2/23/96.
MANUFACTURER Joey Oysters, Inc., Amite, Louisiana.
RECALLED BY Manufacturer, on or about February 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Louisiana, Tennessee, Texas, Mississippi.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between the dates
1/23 - 2/23/96 have been associated with
outbreaks of gastroenteritis.
_______________
PRODUCT Shellstock Oysters harvested at Drum Bay,
Black Bay, Lake Fortuna, or Lake Machias,
Louisiana. Recall #F-462-6.
CODE Harvest dates of 1/23 - 2/23/96.
-6- MANUFACTURER Yscloskey Seafood, St. Bernard, Louisiana.
RECALLED BY Manufacturer, by telephone immediately
following notification from the State of
Louisiana on February 23, 1996. Firm-
initiated recall complete.
DISTRIBUTION Mississippi, Georgia, Louisiana.
QUANTITY Approximately 1,752 100-pound sacks of oysters
were distributed; firm estimates none remains
on the market.
REASON Oysters harvested at Drum Bay, Black Bay, Lake
Fortuna, or Lake Machias, LA between 1/23 -
2/23/96 have been associated with outbreaks of
gastroenteritis.
_______________
PRODUCT Fudge Bars, 2.5 ounces, 12 bars per carton,
under Yukon, Shop-Rite, and SeaWay labels.
Recall #F-465-6.
CODE 0296, 0526, 0626, 0696 (Yukon brand); 102996
(Shop-Rite brand); 0296 (SeaWay brand).
MANUFACTURER Superior Dairy, Inc., Canton, Ohio.
RECALLED BY Manufacturer, by telephone on March 14-15,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, Kentucky, Michigan, Pennsylvania, West
Virginia, New Jersey.
QUANTITY 1,523 cases (219,312 fudge bars) were
distributed; firm estimates little, if any,
product remained on market at time of recall
initiation.
REASON The products cause burning sensation in mouth
and/or stomach and may be contaminated with
calcium chloride.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Anne's Original Honey Sesame Yogurt Salad
Dressing, in 8 ounce glass bottles.
Recall #F-364-6.
CODE Lot numbers: 112455 and 215355.
MANUFACTURER Schlotterbeck & Foss, Portland, Maine.
RECALLED BY Anne Lanyi Foods, Inc., Whispering Pines,
North Carolina, by telephone in May 1995.
Firm-initiated recall complete.
DISTRIBUTION New Jersey, New Hampshire, South Carolina.
QUANTITY Approximately 800 cases.
REASON The product is effervescing out of containers.
_______________
PRODUCT Land O' Lakes Foodservice Butter, net weight 1
pound. Recall #F-382-6.
-7- CODE All one pound packages with T in the code.
All cases with two or more lines of
production/expiration code dating.
MANUFACTURER California Milk Producers, Tipton, California.
RECALLED BY Land O'Lakes, Inc., Arden Hills, Minnesota, by
notice sent on December 8, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 27,641 cases (36 1-pound packages per case)
were distributed.
REASON The product is adulterated due to the L-219
black ink, used for packaging, migrating into
the product.
_______________
PRODUCT Chef's Cupboard Condensed Cream of Mushroom
Soup, in 10.5 ounce cans. Recall #F-464-6.
CODE P-51 0336RN09-47.
MANUFACTURER H.J. Heinz, Pittsburgh, Pennsylvania.
RECALLED BY Aldi, Inc., Batavia, Illinois, by fax sent on
March 22, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois, Iowa, Ohio, Wisconsin, Pennsylvania,
Missouri, New Jersey, New York.
QUANTITY 1,100 cases (24 cans per case) were
distributed.
REASON Some of the cans may contain chicken noodle
soup instead of the labeled cream of mushroom
soup.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Oxygen USP packed in various size of Luxfer
aluminum high pressure cylinders including
"D", "E", and "N". Recall #D-119-6.
CODE Various codes.
MANUFACTURER Providence Medical Supply, Olympic Washington.
RECALLED BY Manufacturer, by visit beginning February 28,
1996. FDA-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 103 cylinders were distributed.
REASON Current good manufacturing practice
deficiencies.
_______________
PRODUCT Metoclopramide Tablets USP, in bottles of 500,
Rx single ingredient anti-emetic/nauseant,
under the Biocraft, Major, and Qualitest
labels. Recall #D-122-6.
CODE Lot #22939 EXP 4/1/97.
MANUFACTURER Biocraft Laboratories, Inc., Paterson, New
Jersey.
-8- RECALLED BY Biocraft Laboratories, Inc., Fairlawn, New
Jersey, by letter on January 30, 1996. FDA-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,738 bottles were distributed; firm estimated
that 374 bottles remained on market at time of
recall initiation.
REASON Product does not meet content uniformity
specifications.
_______________
PRODUCT Revco Brand Su-phedrine Cough & Cold liquid
caps, an OTC multi-symptom capsule, packaged
as 30's (20 liquid caps plus 10 free).
Recall #D-123-6.
CODE Lot numbers and EXP dates: FI1496 9/97,
FI1497 9/97, FI1498 9/97.
MANUFACTURER Private Formulations, Division of
Pharmaceutical Formulations Inc, Edison, New
Jersey (repacker/responsible firm).
RECALLED BY Repacker, by letter dated January 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Tennessee, South Carolina,
Indiana.
QUANTITY Firm estimated that 20,146 packs remained on
market at time of recall initiation.
REASON Incorrect statement in Drug Interaction
Precaution Section.
_______________
PRODUCT Dihistine DH Elixir in 4 ounce, 8 ounce, 1
pint, and 1 gallon containers, a cough
suppressant-nasal decongestant-antihistamine,
under the Barre, Rugby, H.L. Moore and Schein
labels. Recall #D-124-6.
CODE Lot Exp.
RF4305 6/96
RL4579 10/96
RA5018 1/97
VD5226 6/97
RL5565 9/97
RP5733 11/97
VS5831 1/98
RB6054 3/98
RP4761 12/96
VB5082 5/97
VC5184 6/97
RJ5416 9/97
RK5506 9/97
RN5637 11/97
RP5734 11/97
VS5831 1/98
RL5564 9/97.
-9- MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated April 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 677,130 units were distributed; firm estimated
that 131,165 units remained on market at time
of recall initiation.
REASON Product does not bear warning statements in
accordance with CFR.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Hydrocodone Bitartrate and Acetaminophen
Tablets, USP, 5 mg/500 mg, in packets of 500,
Rx analgesic. Recall #D-120-6.
CODE Lot #8705.
MANUFACTURER Zenith Goldline Pharmaceuticals (Zenith
Goldline Shreveport, Inc.), Shreveport,
Louisiana.
RECALLED BY Manufacturer, by letter of April 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,996 packets were distributed.
REASON Current good manufacturing practice
deficiencies.
_______________
PRODUCT Baclofen USP 10 mg Tablets, in 100 unitdose
packages, a muscle relaxant and antispastic.
Recall #D-121-6.
CODE Lot #CDT074 EXP 4/19/96.
MANUFACTURER Danbury Pharmaceutical, Inc., Danbury,
Connecticut.
RECALLED BY Schein Pharmaceutical, Inc., Florham Park, New
Jersey, by letter on August 29, 1995, November
9, 1995, and January 12, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 5,904 unitdose boxes were distributed; firm
estimated that 300 unit dose boxes remained on
market at time of recall initiation.
REASON Marginally subpotent.
_______________
PRODUCT Decadron 0.25 mg Tablets, in bottles of 100,
144 market packages per packer, Rx
corticosteroid. Recall #D-125-6.
CODE Lot #A6685 EXP 5/31/96, #W0900 EXP 8/96.
MANUFACTURER Merck Manufacturing Division, Division of
Merck & Company,Inc., West Point,
Pennsylvania.
-10- RECALLED BY Manufacturer, by letter dated April 12, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,932 market packages were distributed.
REASON Lot A6685 failed stability testing. Lot W0900
lacks assurance of stability.
_______________
PRODUCT Soluvite C.T., chewable tablets in bottles of
100, Rx vitamin containing fluoride and 0.3 mg
of folic acid. Recall #D-126-6.
CODE Lot #3128A.
MANUFACTURER Gull Laboratories, Inc., Murray, Utah.
RECALLED BY Pharmics, Inc., Salt Lake City, Utah, by
letters faxed beginning March 25, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Utah, Wyoming, Idaho, Nevada, Colorado,
Arizona, Ohio, Texas, Washington state.
QUANTITY 777 bottles were distributed; firm estimated
that 150 bottles remained on market at time of
recall initiation.
REASON Subpotency of folic acid ingredient.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-352-6.
CODE Unit #11313-1663.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, El Paso, Texas.
RECALLED BY Manufacturer, by letter January 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Mexico.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but was collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Recovered Plasma. Recall #B-353/355-6.
CODE Unit numbers: (a) 55C75786, 55R77750; (b)
55C75786; (c) 55KR04913, 55R77750.
MANUFACTURER American Red Cross Blood Services, Little
Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on January 25 and
26, 1995, followed by letter February 2, 1995.
Firm-initiated recall complete.
DISTRIBUTION Arkansas, California.
QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units.
-11- REASON Blood products, collected from a donor taking
the drug Proscar, were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c)
Platelets; (d) Fresh Frozen Plasma.
Recall #B-375-378-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
MANUFACTURER American National Red Cross and American Red
Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone followed by letters
of May 10, 1994, June 7, 1994, and April 27,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas, Oklahoma.
QUANTITY (a) 18 units; (b) 1,464 units; (c) 909 units;
(d) 59 units.
REASON Blood products untested for syphilis was
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-380-6.
CODE Unit #T83448.
MANUFACTURER Topeka Blood Bank, Inc., Topeka, Kansas.
RECALLED BY Manufacturer, by letter March 20, 1995. Firm-
initiated recall complete.
DISTRIBUTION Kansas.
QUANTITY 1 unit.
REASON Blood product, which was incorrectly tested
for the antibody to the hepatitis B core
antigen (anti-HBc), was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-381-6.
CODE Unit #56G59582.
MANUFACTURER American Red Cross Blood Services, Rochester,
New York.
RECALLED BY Manufacturer, by letter dated September 5,
1995. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood products, which tested repeatedly
reactive for HBsAg, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-379-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
-12- MANUFACTURER American National Red Cross and American Red
Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone followed by letters
of May 10, 1994, June 7, 1994, and April 27,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas, Oklahoma.
QUANTITY 298 units.
REASON Blood product untested for syphilis was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma; (c)
Platelets. Recall #B-382/384-6.
CODE Unit numbers: (a) 56H28205, 56H28223; (b)
56H28205; (c) 56H28205, 56H28223.
MANUFACTURER American Red Cross Blood Services, Rochester,
New York.
RECALLED BY Manufacturer, by letter dated September 5,
1995, and by letters sent sometime between
September 7 and October 31, 1995. Firm-
initiated recall complete.
DISTRIBUTION New York, California, Switzerland.
QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units.
REASON Blood products which tested repeatedly
reactive for HBsAg were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-385-6.
CODE Unit #12415-6575.
MANUFACTURER United Blood Services, Albuquerque, New
Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on March 1, 1996. Firm-initiated
recall complete.
DISTRIBUTIOn New Mexico.
QUANTITY 1 unit.
REASON Blood product labeled with an extended
expiration date was distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red
Blood Cells, Leukocytes Removed; (d)
Platelets; (e) Platelets, Pooled; (f) Fresh
Frozen Plasma. Recall #B-386/391-6.
CODE Unit numbers: (a) 1220616, 1220623, 1220634,
1220637
(b) 1220594, 1220595, 1220596, 1220597,
1220598, 1220599, 1220600, 1220603, 1220607,
1220608, 1220609, 1220626, 1220629, 1220631,
1220639, 1220640, 1220647, 3127254, 3127255,
4109442, 4109444, 4109446, 4109452, 7166211,
7166213, 7166214, 7166215, 7166220, 7166225,
-13- 7166227, 7166230, 7166231, 7166235, 7166238,
7166239, 7166240, 7166244, 7166246, 7166260,
7252585, 7262587, 7262589, 7262591, 7262592,
7262595, 7262596, 7262600, 7262604, 7262606,
7262608, 7262610, 7262619, 7262626, 7262627,
7262633, 9125890, 9125891, 9125892, 9125893,
9125894, 9125895, 9125896, 9125904, 9125906,
9125908, 9125909, 9125910, 9222424, 9222425,
9222426, 9222427, 9222432, 9222434, 9222435,
2410159, 2410160
(c) 1220592, 1220606, 1705859, 2410161,
2410164, 3127251, 3127252, 4806522, 4806523,
2410162
(d) 1220589, 1220590, 1220591, 1220598,
1220608, 1220609, 1220640, 1229598, 1500415,
1500416, 3127251, 3127252, 4109442, 4109444,
4806522, 4806523, 7262588, 7262589, 7262591,
7262592, 7262600, 7262604, 7262610, 7262633
(e) P54146, P54161, P54165
(f) 1220592, 1220596, 1220598, 1220604,
1220606, 1220607, 1220608, 1220609, 3127251,
3127252, 3127255, 4109444, 4109446, 7262591,
7262596, 7262597, 7262604, 7262608, 7262613,
7262618, 7262642.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by letter dated March 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY (a) 4 units; (b) 76 units; (c) 10 units; (d)
24 units; (e) 3 units; (f) 21 units.
REASON Blood products, incorrectly tested for
antibody to the human immunodeficiency virus
type 2 (anti-HIV-2), were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Siemens Color Monitors, Computer Monitors
Associated with various Automated Equipment.
Recall #Z-601/605-6.
CODE (a) Model No. 6AV80111LE620KA0;
(b) Model No. 6DS34041AB01;
(c) Model No. 6AV80211FE220CA0;
(d) Model No. 6AV80111FE121AA0;
(e) Model No. 6AV85111FD212CA1.
MANUFACTURERS (a) Siemens AG, Oestl. Rheinbrueckenstr. 50,
76181 Karlsruhe, Germany;
(b) Siemens AG, Oestl. Rheinbrueckenstr. 50,
76181 Karlsruhe, Germany;
(c) Siemens AG, Oestl. Rheinbrueckenstr. 50,
76181 Karlsruhe, Germany;
-14- (d) Aschenbrenner Geraepebau GmbH, Nurnberg, Germany;
(e) Mitsubishi, Japan.
RECALLED BY Siemens Energy and Automation, Inc., Johnson
City, Tennessee. FDA approved the firm's
corrective action plan on February 29, 1996.
FDA-initiated recall complete.
DISTRIBUTION Alabama, Connecticut, Kentucky, Minnesota,
Nebraska, North Carolina, Ohio, Pennsylvania.
QUANTITY 13 monitors were distributed.
REASON The manufacturer of the television products
failed to comply with the Federal requirements
for reporting, 21 CFR 1002.10,
recordkeeping, 21 CFR 1002.30, and
certification, 21 CFR 1010.2.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Toshiba Digital Gammacameras, designed for
whole body diagnostic examinations:
(a) Model GCA-7100A; (b) Model GCA-7200A.
Recall #Z-606/607-6.
CODE Serial numbers: (a) 4592004, 4622008, and
4622019;
(b) 4522007, 4572009, 4582028, 4582029,
4582030, 4582032, 4592040, 4682042, 4682043,
4682044, 4682045, 4682046, A4622048, A4622051,
A4622052, A4622054, A5522058, A5522060,
A5522061, A5522062, and A5542049.
MANUFACTURER Toshiba Medical, Tochigi, Japan.
RECALLED BY Toshiba America Medical Systems, Inc. (TAMS),
Tustin, California, by letter on August 28,
1995. Firm-initiated field correction
complete.
DISTRIBUTION Alabama, California, Florida, Georgia,
Illinois, Indiana, Michigan, North Carolina,
New Jersey, Nevada, Ohio, Pennsylvania, Rhode
Island, Texas, Virginia.
QUANTITY 22 units were distributed.
REASON Uncontrolled detector head drift can cause the
detector to come in contact with the patient
with a maximum force of 27 kg.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
=========
_______________
PRODUCT Vitamin K1 Injection (Phytonadione), 100 ml
multiple dose vials, Rx drug for acute and
nonacute hypoprothrombinemia in dogs and cats,
under the following labels: Veta-K1,
manufactured for Sanofi Animal Health,
Overland Park, Kansas and Veda-K1,
-15- manufactured for VEDCO, Inc., St. Joseph,
Missouri. Recall #V-013-6.
CODE Lot #51169 EXP 1/97.
MANUFACTURER Rhone Merieux, Inc., Fort Dodge, Iowa.
RECALLED BY Rhone Merieux, Inc., Athens, Georgia, by
letter dated March 20, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 5,727 vials were distributed.
REASON Misalignment of the filling needles during the
filling process resulted in glass particles in
the vials. The needles would strike the sides
of the vials causing chipping.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
========
_______________
PRODUCT Myosel-E Selenium Vitamin E Injection, 100-ml
vials, Rx for the prevention and treatment of
myositis syndrome in horses. Recall #V-012-6.
CODE Lot #5-FBR-06 EXP 10/97.
MANUFACTURER Schering-Canada, Pointe Claire, Quebec,
Canada.
RECALLED BY Schering Plough Animal Health, Schering Plough
Corporation, Union, New Jersey, by letter sent
on March 1, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,224 vials were distributed.
REASON Product is mislabeled. The product is
approved for intravenous or intramuscular use
in horses only but was labeled on the outer
carton for subcutaneous or intramuscular
injection. The contraindication information
on the outer carton stated it is
contraindicated in adult dairy cows. The
product is approved for use in horses only.
-16-
END OF ENFORCEMENT REPORT FOR APRIL 24, 1996. BLANK PAGES MAY
FOLLOW.
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