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
06/08/1994
Recalls and Field Corrections: Foods -- Class II -- 06/08/1994
June 8, 1994 94-23
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
==========================
_______________
PRODUCT Processed Fresh Shucked Oysters, harvested at Cabbage Reef
and Grand Pass, packed in pints, quarts, 1/2 gallon and
gallon tubs. Recall #F-414-4.
CODE All products are coded USE/Freeze By 11/27/93 and 11/29/93.
MANUFACTURER Carmel Seafood, Lakeshore, Mississippi.
RECALLED BY Tubby's/Ken's Seafood, Inc., Lakeshore, Mississippi, by
telephone November 15-22, 1993. Firm-initiated recall
complete.
DISTRIBUTION Louisiana, Texas.
QUANTITY 700 gallons.
REASON The oysters have been associated with at least 16 discreet
outbreaks of gastroenteritis.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT K-Dur 20 (Potassium Chloride), potassium supplement, in
bottles of 100, an extended release tablet providing 150 mg
KC1 per tablet. Recall #D-292-4.
CODE Lot #00673.
MANUFACTURER Key Pharmaceuticals, Inc., Kenilworth, New Jersey.
RECALLED BY Duramed Pharmaceuticals, Inc., Cincinnati, Ohio (repacker),
by letter November 22, 1993. Firm-initiated recall
complete.
DISTRIBUTION Georgia.
QUANTITY 503 cases (12 bottles per case) were distributed.
REASON Some cases of the product contained all uncapped and
unsealed bottles.
_______________
PRODUCT Myphetane DC Cough Syrup; Brompheniramine Maleate 2 mg/5 ml,
Phenylpropanolamine Hydrochloride 12.5 mg/5 ml and Codeine
Phosphate 10 mg/5 ml; Rx, for the relief of coughs and upper
respiratory symptoms, sold under the following labels:
Pennex Myphetane DC Cough Syrup, Manufactured By: Pennex
Pharmaceuticals, Inc., Morton Grove, IL; Major Diamine DC
Cough Syrup, manufactured for Major Pharmaceuticals, Inc.,
Chicago, IL/Distributor; H.L. Moore Brompheniramine Compound
with Codeine Cough Syrup, distributed by H.L. Moore, New
Britain, CT; Schein Bromphen DC Cough Syrup, distributed by
Schein Pharmaceutical, Inc., Florham Park, NJ; GG
Brompheniramine DC Cough Syrup, distributed by Geneva
Pharmaceuticals, Inc., Broomfield, CO. Recall #D-293-4.
CODE Lot #19986 EXP 09/30/95.
MANUFACTURER Pennex Pharmaceuticals, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter June 1, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 73,343 4-ounce bottles and 944 gallon bottles were
distributed; firm estimated that 33 percent of the product
remained on the market at time of recall.
REASON Product exceeds microbial limits specification.
_______________
PRODUCT Erythromycin Topical Solution, USP, 2% (20 mg/ml); Rx
antibiotic lotion used for the topical control of acne
vulgaris in 2 fluid ounce bottles under the following
labels: Pennex, manufactured by: Pennex Pharmaceuticals,
Inc., Morton Grove, IL; PBI, manufactured by Pharmaceutical
Basics, Morton Grove, IL; H.L. Moore, distributed by H.L.
Moore, New Britain, CT; GG, distributed by Geneva
Pharmaceuticals, Inc., Broomfield, CO; Aligen, distributed
by Aligen Independent Laboratories, Inc., Jackson, Wyoming.
Recall #D-294-4.
CODE Lot numbers: 19726, 19830, 19963, 19964, 19969, 20118.
MANUFACTURER Pennex Pharmaceuticals, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter June 1, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 104,236 bottles were distributed; firm estimated that 33
percent of the product remained on the market at time of
recall.
REASON Product was tested at an unapproved laboratory.
-2- _______________
UPDATE Triamcinolone Acetonide Lotion, 0.025%, Recall #D-280-4,
manufactured by Pennex Pharmaceuticals, Inc., which appeared
in the May 25, 1994 Enforcement Report should read:
CODE: Lot numbers: 19582, 19768, 19823, 20001, 20096,
20153.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets, Expired;
(d) Recovered Plasma. Recall #B-271/274-4.
CODE Unit numbers: (a) 04H21500, 04J55186, 04M14650, 04S74246,
04Y58835; (b) 04J55186, 04M14650, 04S74246; (c) 04H21500;
(d) 04H21500, 04M14650, 04S74246, 04Y58835, 05J55186.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters of November 18, 1992 through
November 15, 1993, January 13, 1993, February 11, 1993, and
March 19, 1993. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, California.
QUANTITY (a) 5 units; (b) 3 units; (c) 1 unit; (d) 5 units.
REASON Blood products, which tested non-reactive for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
________________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Plasma; (d) Fresh
Frozen Plasma; (e) Platelets for Further Manufacture; (f)
Source Leukocytes; (g) Recovered Plasma.
Recall #B-290/296-4.
CODE Unit numbers: (a) 1074925, 1083558, 1084916, 1086125,
1087734, 1088429, 1089853, 1089867, 1090942, 1091511,
1092151, 1092271, 1092312, 1093021, 1093931, 1094134,
1095675, 1095945, 1096448, 1096797, 1097443, 1097846,
1098252, 1115605, 1115616, 1116043, 1116498, 1229689,
1353236, 1402906, 1402922, 1403489, 1520453, 2000732,
2000734, 2000930, 2002094, 2002833, 2002844, 2003749,
2004704, 2006329, 2006430, 2007664, 2008928, 2008977,
2009015, 2010333, 2012576, 2012636, 2101130, 2101527,
2300600, 2300621, 2306127, 2308689, 2403316, 2403961,
2406954, 2407995, 2408571, 2505312, 2506737, 2507679,
2601581, 2604375, 2605333, 2700009, 2700084, 2700507,
2701818, 5923294, 6901898, 6902830, 9204088, 9204839,
9205973, 9207680, 9209559, 9604583, 9608236;
(b) 1083558, 1087734, 1088429, 1089867, 1090942, 1091551,
1093021, 1093931, 1094134, 1095945, 1096448, 1097443,
1098252, 1115605, 1115616, 1116498, 1353236, 1402906,
1402922, 1403489, 2000732, 2000734, 2002094, 2002833,
2002844, 2004704, 2006329, 2007664, 2008928, 2008977,
2010333, 2012576, 2101130, 2101527, 2300600, 2300621,
2308689, 2403316, 2403961, 2407995, 2408571, 2506737,
-3- 2507679, 2601581, 2604375, 2700009, 2701818, 5504305,
5923294, 6902830, 9204088, 9207680, 9209559, 9608236;
(c) 2003749, 2006430, 2406954, 2700084;
(d) 1074925, 1084916, 1097443, 1097846, 1116043, 2002094,
2006329, 2008977, 2012636, 2101527, 2308689, 2403961,
2505312, 2601581, 2700507, 2701818;
(e) 1084916, 1086125, 1089853, 1092271, 1092312, 1095675,
1096797, 2000930, 2012636, 2306127, 2505312, 2700507,
9204839, 9604583;
(f) 9204839, 9604583, 9608236;
(g) 1083558, 1086125, 1087734, 1088429, 1089853, 1089867,
1090942, 1092151, 1092271, 1092312, 1093021, 1093931,
1094134, 1095675, 1095945, 1096448, 1096797, 1098252,
1115605, 1115616, 1116498, 1229689, 1353236, 1402906,
1402922, 1403489, 1520453, 2000732, 2000734, 2000930,
2002833, 2002844, 2003749, 2004704, 2006430, 2007664,
2010333, 2012576, 2101130, 2300600, 2300621, 2306127,
2403316, 2406954, 2407995, 2408571, 2506737, 2507679,
2604375, 2605333, 2700009, 2700084, 5504305, 5923294,
6901898, 6902830, 9204088, 9204839, 9207680, 9209559,
9604583, 9608236.
MANUFACTURER Hunter Blood Center, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letters of, November 22, 1993, and December
7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY (a) 81 units; (b) 54 units; (c) 4 units; (d) 16 units; (e)
14 units; (f) 3 units; (g) 62 units.
REASON Blood products, that either: tested negative for hepatitis
B surface antigen (HBsAg), but were collected from a donor
who previously tested repeatedly reactive for HBsAg; or
tested negative for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-311-4.
CODE Unit #931158.
MANUFACTURER Hays Community Blood Bank, Hays Pathology Laboratories,
P.A., Hays, Kansas.
RECALLED BY Manufacturer, by telephone October 12, 1993. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product collected from a donor currently taking the
drug Proscar was distributed.
_______________
PRODUCT Standardized Cat Hair (Felis domesticus), allergenic
extract. Recall #B-313-4.
CODE Lot #C39043093.
MANUFACTURER Antigen Laboratories, Inc., Liberty, Missouri.
-4- RECALLED BY Manufacturer, by telephone January 19, 1994, and by letter
January 21, 1994. Firm-initiated recall complete.
DISTRIBUTION Wisconsin, Florida, Iowa, Washington state, Missouri,
Louisiana, Texas, Ohio.
QUANTITY 38 vials were distributed; firm estimates none remains on
the market.
REASON Product which was labeled without the appropriate warning
statement was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets, Expired; (c) Red Blood
Cells, For Further Manufacture; (e) Cryoprecipitated AHF;
(f) Fresh Frozen Plasma; (g) Recovered Plasma.
Recall #B-275/281-4.
CODE Unit numbers: (a) 04C17643, 04F06443, 04FC51677, 04GF56801,
04GF58444, 04GF60232, 04GF64890, 04KK87617, 04KK90263; (b)
04F06443, 04GF58444, 04GF60232, 04KK90263; (c) 04C17643,
04GF63060; (d) 04GF3060; (e) 04KK87617, 04KK90263; (f)
04F06443, 04C17643; (g) 04FC51677, 04GF56801, 04GF58444,
04GF60232, 04GF63060, 04KK87617, 04KK90263.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters dated from November 18, 1992
through November 15, 1993, January 13, 1993, February 11,
1993, March 19, 1993, and Letters dated November 19, 1992
through November 15, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, New York, California, Switzerland.
QUANTITY (a) 9 units; (b) 4 units; (c) 2 units; (d) 1 unit;
(e) 2 units; (f) 2 units; (g) 7 units.
REASON Blood products, which tested non-reactive for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Recovered Plasma Recall #B-314-4.
CODE Unit #21M93881.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter June 28, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Recovered Plasma, corresponding to a unit of Red Blood Cells
contaminated with Enterobacter agglomerans and
Pseudomonas sp., was distributed.
-5- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
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PRODUCT Various Sterile Surgical Devices:
(a) Marking Pens, Catalog Nos. 100, 110, 115, 130, 200, 215,
230; (b) Cautery Tip Cleaner, Catalog No. 8101;
(c) Light Shields, Catalog Nos. 8001, 8002, 8003;
(d) Needle Counters, Catalog Nos. 2101, 2103, 2104, 2105,
2106, 2108, 2206, 2210, 4101, 4102, 4131, 5101, 5102, 5103,
5106, 5107, 5167, 9020, 9030, 9040, 9101, 9102, 9103, 9105,
9106, 9107, 9108, 9910, 9220, 9600;
(e) Convenience Kit, Catalog Nos. K-2101-A, K-2101-J,
K-2101-L, K-2103-G, K-2103-I, K-2103-J, K-2103-N, K-2104-E,
K-2104-I, K-2106-A, K-2106-E, K-2106-Z, K-4102-J, K-5102-I,
K-5103-I, K-5106-A, K-5106-E, K-5106-J, K-9102-G, K-9103-E,
K-9103-Q, K-9106-G, K-9106-I,K-9106-J, K-9107-E.
Recall #Z-885/889-4.
CODE Lot numbers: 92335 through 92365, and 93006 through 93115.
MANUFACTURER Quan Tech, Inc., New Albany, Indiana.
RECALLED BY Manufacturer, by telephone, followed by letter dated May 3,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Firm estimates little if any product remains on the market.
REASON The devices, labeled as sterile, were distributed without
documentation to indicate that they were sterilized.
_______________
PRODUCT Deknatel Gut Absorbable Suture, USP, indicated for use
wherever absorbable surgical suture, USP is recommended
except Ophthalmic surgery:
(a) Gut Plain, Catalog #G-504;
(b) Gut Chromic, Catalog numbers G-860, G-501, G-340,
G-5089, G-502, G-535, R-222. Recall #Z-898/899-4.
CODE Lot numbers: (a) 02783; (b) 02360, 02860, 02783, 02830,
02893, 02419, 0272.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by telephone, followed by letter March 18,
1994. Firm-initiated ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 72 pieces; (b) 72 pieces.
REASON Primary product foil pouches were found to be leaking the
alcohol mixture contained within the pouches through the
foil seal, which may compromise the sterility of the device.
_______________
PRODUCT Silk 5-0 Neurosurgery Surgical Suture (black), code #S-7168,
used wherever nonabsorbable surgical suture, USP is
recommended, except ophthalmic surgery. Recall #Z-900-4.
CODE Lot #02213.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by telephone, followed by letter March 18,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Arizona.
-6- QUANTITY 150 pouches were distributed.
REASON The inner foil pack was found to intrude into the outer
pouch seal, which may compromise the sterility of the
device.
_______________
PRODUCT Silk 3-0 Cuticular Non-absorbable Surgical Suture (black)
code S-590, used wherever nonabsorbable surgical suture, USP
is recommended except ophthalmic surgery. Recall Z-901-4.
CODE Lot #01654.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by telephone, followed by letter March 18,
1994. Firm-initiated recall ongoing.
DISTRIBUTION California, New Jersey, Georgia.
QUANTITY 288 pouches were distributed.
REASON The inner foil pack was found to intrude into the outer
pouch seal, which may compromise the sterility of the
device.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Abbott ADx Barbiturates Serum Reagent KitPack, in-vitro
diagnostic for use for the detection of barbiturates in
serum plasma on the ADx System Analyzer. Recall #Z-754-4.
CODE List #9679-55, lot #71214M200 EXP 9/93.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone December 22, 1992. Firm-
initiated recall complete.
DISTRIBUTION California, Kentucky, Michigan, Nevada, New Jersey, New
York, Texas, Canada, Italy, Germany.
QUANTITY 363 kits were distributed.
REASON The reagent vials were packed in the wrong order in a
portion of this lot. This would result in an intensity
error on any calibration or sample runs.
_______________
PRODUCT Ventrescreen Strep A 20 Test Kits, used for enzyme
immunoassay for the qualitative detection of Group A
streptococcal antigen directly from throat swabs, or for
confirmation of the antigen in clinical isolates from
culture plates. Recall #Z-832-4.
CODE Lot numbers: 41192 EXP 5/11/94, 41232 EXP 5/11/94.
MANUFACTURER Hycor Biomedical, Inc., Garden Grove, California.
RECALLED BY Manufacturer, by letter January 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Colorado, Florida, Illinois, Indiana, Kentucky,
Massachusetts, Maryland, Michigan, North Carolina, New
Mexico, Pennsylvania, Tennessee, Texas, Virginia, Washington
state.
QUANTITY 138 kits were distributed; firm estimates that little if any
product remains on the market.
-7- REASON The chromogen solution and wash solution are mislabeled
resulting in incorrect test results for patient samples.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Sodium Ascorbate Injection, 250 mg/ml, in 100 ml bottles.
Recall #V-044-4.
CODE Lot #940128.
MANUFACTURER Radix Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY Manufacturer, by letter May 11, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Florida.
QUANTITY 5,180 bottles were distributed.
REASON Precipitate in product.
________________
PRODUCT Parenteral products for injection:
(a) Milk Fever 23%, labeled as a nutritional supplement for
bovine, sold under Radix Labs, Cherry Valley Veterinary
Associates, River Valley Veterinary Clinic, Attica
Veterinary Associates and Perry Veterinary Clinic brand
names;
(b) Cumberland Veterinary Clinic Calcium Borogluconate,
labeled as a treatment for milk fever in cattle;
(c) Milk Fever 2, labeled as a source of sterile injectable
calcium, phosphorous, magnesium and dextrose for the
treatment of milk fever, grass tetany and other conditions
in cattle, swine and sheep where calcium, phosphorus, and
magnesium deficiencies may occur, sold under Radix Labs,
Cherry Valley Veterinary Associates, River Valley Veterinary
Clinic, and Town & Country Veterinary Service brand names;
(d) Radix Labs Milk Fever S, labeled as a source of sterile
injectable calcium, phosphorus, magnesium and dextrose for
use in the treatment of milk fever in cattle;
(e) Milk Fever K, labeled as a source of sterile injectable
calcium, potassium and dextrose for the treatment of milk
fever in cattle, sold under Radix Labs and Cherry Valley
Veterinary Associates brand names;
(f) Milk Fever Forte, labeled as an aid in the treatment of
hypocalcemia, hypomagnesemia and other conditions associated
with calcium, phosphorus, and magnesium deficiencies in
cattle, sold under Radix Labs, Town & Country Veterinary
Service and Grassland Veterinary Service brand names;
(g) Radix Labs CMPK, labeled as a nutritional supplement for
cattle. Recall #V-045/051-4.
CODE Lot numbers: (a) R3H001, R3J004, R3L006; (b) R3K007;
(c) Lots R3J002, R3J002, R3N002; (d) R3K004, R3P006;
(e) R3L009; (f) R3N007; (g) R3E005, R3N008.
MANUFACTURER Radix Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY Manufacturer, by telephone April 8, 1994, and by letter
dated April 11, 1994. Firm-initiated recall ongoing.
-8- DISTRIBUTION Alabama, California, Illinois, Iowa, Massachusetts,
Minnesota, New Jersey, New York, Oklahoma, Pennsylvania,
South Carolina, Tennessee, Virginia, Washington state,
Wisconsin, Puerto Rico.
QUANTITY (a) 12,056 500-ml bottles and 588 1000-ml bottles;
(b) 11,635 500-ml bottles; (c) 2,297 500-ml bottles;
(d) 240 500-ml bottles; (f) 988 500-ml bottles;
(g) 10,930 500-ml bottles were distributed.
REASON Precipitates found in parenteral products for injection.
-9-
END OF ENFORCEMENT REPORT FOR JUNE 8, 1994. BLANK PAGES MAY FOLLOW.
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