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
07/14/1993
Recalls and Field Corrections: Foods -- Class I -- 07/14/1993
July 14, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Soylac Powder, Infant Formula, in 14
ounce cans.
Recall #F-492-3.
CODE Recall Extended on June 22, 1993 to
include all lots with partial code
W5330. NO 94/W5310/923081 (Canadian)
and NOV 94/W5330/923082 (US).
MANUFACTURER Nutricia, Inc., Mt. Vernon, Ohio.
RECALLED BY Manufacturer, by memorandum dated March
24, 1993, and by press release May 21,
1993. Firm-initiated recall complete.
See also FDA press release P93-29, June
29, 1993.
DISTRIBUTION Nationwide, Canada.
QUANTITY Unknown.
REASON The product is contaminated with
Salmonella.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
_______________
PRODUCT Pediatric Electrolyte Oral Maintenance
Solution (unflavored), in 32 fluid
ounce bottles, an OTC oral maintenance
solution used rather than juices, sport
drinks, soft drinks or water to restore
body water and minerals lost in
children's diarrhea and vomiting, under
the following labels: Longs, Thrifty,
Raley's, Smith's Albertson's Valu-Rite,
and Aid-Pack, USA. Recall #F-491-3.
CODE Lot numbers 2TPU-19, 2TPU-31, 2TPU-33,
EXP 12/95.
MANUFACTURER Aid-Pack, USA, Gloucester,
Massachusetts.
RECALLED BY Manufacturer, by telephone April 22,
1993, followed by letter April 29,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,983 cases were distributed.
REASON Product may be contaminated due to
filter failure.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
PRODUCT Lotion under the following labels:
Vitamin E & Lanolin Skin Softening
Lotion, in 10 fluid ounce bottles;
Schwegmann Vitamin E & Lanolin Lotion,
in 15 fluid ounce bottles; Meijer Hand
& Body Lotion Vitamin E & Lanolin, in
15 fluid ounce bottles.
Recall #D-290-3.
CODE Lot numbers: 205061, 22651, 22661,
209221, 209301, 211161, 211231, 212021,
301251, 302021, 302022.
MANUFACTURER Benjamin Ansehl Company, St. Louis,
Missouri.
RECALLED BY Manufacturer, by letter May 28, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Michigan, Pennsylvania, South Carolina,
Kansas, Louisiana.
QUANTITY 4,200 cases (12 bottles per case) were
distributed.
REASON Presence of mold in the product.
_______________
PRODUCT Indomethacin Extended Release Capsules,
USP, 75 mg, for oral administration, in
60 and 100 capsule bottles, Rx
nonsteroidal anti-inflammatory. Recall
#D-292-3.
CODE Lot #1J105 EXP 1/94.
MANUFACTURER Inwood Laboratories, Inc., Inwood, New
York.
RECALLED BY Manufacturer, by telephone and by
letter May 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 2,040 60-capsule bottles and 8,684 100-
capsule bottles were distributed.
REASON Product does not meet dissolution
specifications.
_______________
PRODUCT Shampoo: (a) Head and Shoulders Dry
Scalp, Dandruff Shampoo, Plus
Conditioner, in 12.5 ounce bottles; (b)
Head & Shoulders, Dandruff Shampoo,
Fine or Oily Hair, in 11 ounce and 15
ounce bottles. Recall #D-293/294-3.
CODE Lot numbers: Day codes (a) 3159; (b)
3165, 3163.
MANUFACTURER The Procter & Gamble Manufacturing
Company, Iowa City, Iowa.
RECALLED BY Procter & Gamble Company, Cincinnati,
Ohio, by letter June 29, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 904 cases (12 bottles per case) were
distributed.
REASON Presence of Pseudomonas cepacia.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Promethazine containing Rx oral liquid
cough and cold preparations
manufactured by Pharmaceutical Basics,
Inc., all products were produced in 4-
ounce, 1-pint and 1-gallon bottles:
(a) Promethazine with Dextromethorphan
Cough Syrup, Promethazine
Hydrochloride, U.S.P. 6.25 mg/5 ml &
Dextromethorphan Hydrobromide,
U.S.P. 15 mg/5 ml, product code
8604, packaged under the following
labels: PBI, GG Promethazine DM Cough
Syrup, distributed by Geneva
Pharmaceuticals, Inc.; Major Phenameth
DM Cough Syrup, manufactured for Major
Pharmaceutical Corp.; Rugby
Promethazine DM Cough Syrup,
manufactured for Rugby Laboratories,
Inc.;
(b) Promethazine VC Plain Syrup,
Promethazine Hydrochloride 6.25 mg/5 ml
& Phenylephrine Hydrochloride 5 mg/5
ml, product code 8605, packaged under
the following labels:
PBI; Geneva (GG), Major Phenameth VC
Plain, Rugby,
(c) Promethazine with Codeine Cough
Syrup, Promethazine HCl 6.25 mg/5 ml &
Codeine Phosphate 10 mg/5 ml, a
schedule V narcotic, product 8606,
packaged under the following labels:
PBI, Geneva (GG), Major Phenameth with
Codeine,and Rugby. Recall #D-287/289-3.
CODE All lots.
MANUFACTURER Pharmaceutical Basics, Inc., Morton
Grove, Illinois.
RECALLED BY Pennex Pharmaceuticals, Inc., Morton
Grove, Illinois, by letter June 23,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39,754 units of Promethazine with
Dextromethorphan Cough Syrup; 28,870
units of Promethazine VC Plain Syrup,
and 247,147 units of Promethazine with
Codeine Cough Syrup were distributed;
firm estimates that 30 percent of the
product remains on the market.
REASON Subpotency of the promethazine
ingredient.
_______________
PRODUCT Doxepin Hydrochloride Capsules, in 50
mg bottles of 100 and 1,000, Rx anti-
depressant, under the Rugby label only.
Recall #D-291-3.
CODE CONTROL NO EXP DATE: BOTTLES
OF
E20692 7/94 1000's
F32492 11/94 100's & 1000's
J32892 11/94 1000's
C34392 12/94 100's
C20692 7/94 100's
A04293 2/95 100's
F04993 2/95 100's & 1000's
E07693 3/95 100's
F08193 3/95 1000's.
MANUFACTURER Par Pharmaceutical, Inc., Spring
Valley, New York.
RECALLED BY Manufacturer, by telephone June 25,
1993, followed by letter June 30, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 37,252 bottles were distributed.
REASON Incorrect listing of the color dyes
used for the capsule shell.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma.
Recall #B-303/305-3.
CODE Unit #4015879.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone August 21,
1992, and by letter November 25, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois, New York.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative
for syphilis, but were collected from a
donor who previously tested positive
for syphilis, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-307-3.
CODE 2736699, 2743456, 2743461, 2743484.
MANUFACTURER Department of the Army, Brooke Army
Medical Center, Fort Sam Houston,
Texas.
RECALLED BY Manufacturer, by letter July 1, 1991.
Firm-initiated recall complete.
DISTRIBUTION Florida, Texas.
QUANTITY 4 units.
REASON Blood products, collected from donors
who tested initially reactive: for the
antibody to human immunodeficiency
virus type 1 (anti-HIV-1); or for
hepatitis B surface antigen (HBsAg(,
and were not retested according to the
test kit instructions, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Cryoprecipitated AHF; (d) Fresh Frozen
Plasma; (e) Platelets for Further
Manufacture; (f) Recovered Plasma.
Recall #B-325/330-3.
CODE Unit numbers: (a) 59G56795, 59H05719,
59H25328, 59H31315, 59H35059, 59H37158,
59H41904, 59J51817, 59J54840, 59J57868,
59J58991, 59J60892, 59J71834, 59J85017,
59J98693, 59K11643, 59K22303, 59K24292,
59K31190, 59K35313, 59K40324, 59K43161,
59K46109;
(b) 59H41904, 59H05719, 59K11643,
59J51817, 59J58991, 59K22303, 59K24292,
59J71834, 59K35313, 59H37158;
(c) 59J54840, 59J98693, 59K31190;
(d) 59J85017; (e) 59G56795;
(f) 59G56795, 59H05719, 59H25328,
59H31315, 59H35059, 59H37158, 59J51817,
59J54840, 59J57868, 59J58991, 59J60892,
59J71834, 59J98693, 59K11643, 59K22303,
59K24292, 59K31190, 59K35313, 59K40324,
59K43161, 59K46109.
MANUFACTURER American Red Cross Blood Services,
Flint, Michigan.
RECALLED BY Manufacturer, by telephone and letters
between August 1991 and February 1992.
Firm-initiated recall ongoing.
DISTRIBUTION California, Maine, Maryland,
Massachusetts, Michigan, Northern
Mariana Islands.
QUANTITY (a) 23 units; (b) 10 units; (c) 3
units; (d) 1 unit;
(e) 1 unit; (f) 21 units.
REASON Blood products, which 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.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Auszyme Monoclonal Hepatitis B Surface
Antigen (HBsAg) Test Kit. Recall #B-
306-3.
CODE Lot numbers: 74319M100, 74320M100,
74320M101, 74320M102, 74320M103 EXP
8/28/93.
MANUFACTURER Abbott Laboratories, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by letters sent on April
5, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 6,279 kits were distributed; firm
estimates none remains on the market.
REASON HBsAg test kits, exhibiting decreased
absorbance values of the positive
control, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Cryoprecipitated AHF; (d) Fresh Frozen
Plasma; (e) Platelets for further
Manufacture; (f) Recovered Plasma.
Recall #B-331/336-3.
CODE Unit numbers: (a) 59F73993, 59F75797,
59H01579, 59H11069, 59H13735, 59H17531,
59H19072, 59H25689, 59H28595, 59H33426,
59H35569, 59H37703, 59J01570, 59J51418,
59J61462, 59J64310, 59J64847, 59J75082,
59J78761, 59J87148, 59J87760, 59J92610,
59J98000, 59K19459, 59K21028, 59K26406,
59K29070, 59K35255, 59K44449, 59K48040;
(b) 59F75797; (c) 59J01570; (d)
59F75797, 59H19072;
(e) 59H25689; (f) 59F73993, 59H01579,
59H11069, 59H13735, 59H17531, 59H25689,
59H28595, 59H33426, 59H35569, 59H37703,
59J01570, 59J51418, 59J61462, 59J64310,
59J64847, 59J75082, 59J78761, 59J87148,
59J87760, 59J92610, 59J98000, 59K19459,
59K21028, 59K26406, 59K29070, 59K35255,
59K44449.
MANUFACTURER American Red Cross Blood Services,
Flint, Michigan.
RECALLED BY Manufacturer, by telephone and letters
between August 1991 and February 1992.
Firm-initiated recall ongoing.
DISTRIBUTION California, Maine, Maryland,
Massachusetts, Michigan, Northern
Mariana Islands.
QUANTITY (a) 30 units; (b) 1 unit; (c) 1 unit;
(d) 2 units;
(e) 1 unit; (f) 27 units.
REASON Blood products, which 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 Red Blood Cells. Recall #B-337-3.
CODE Unit 210 N79989.
MANUFACTURER Aurora Area Blood Bank, Heartland Blood
Centers, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone February 15,
1993. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product labeled with the
incorrect expiration date was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
________________
PRODUCT Sterile Silicone Strips, which are
labeled Storz Implant for Retinal
detachment Surgery. Recall #Z-628-3.
CODE 218021684B.
MANUFACTURER Dow Corning Wright, Hemlock, Michigan
(silicone sheets);
Vesta, Inc., Franklin, Wisconsin (cuts,
packages and sterilizes the sheets).
RECALLED BY Storz Instrument Company, St. Louis,
Missouri, by letter February 15, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 50 5-strip packages were distributed.
REASON Product is mislabeled. Product is
labeled as Style 42, Catalog E5381-801,
Size 4 x 1.25 x 125mm, indention 5.9mm.
Actual contents are Style 41, Catalog
#E5381-800, Size 3.5 x 0.75 x 125 mm,
indention 4.8 mm.
_______________
PRODUCT E-Z-Flow Angiographic Catheters.
Recall #Z-631-3.
CODE All product manufactured from January
1989 to August 26, 1991 with various
catalog numbers and multiple lot
numbers from 021301 through 042396.
MANUFACTURER E-Z-EM, Inc., Westbury, New York.
RECALLED BY Manufacturer, by letter April 23, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 62,713 units were distributed
domestically.
REASON The catheter and tubing become brittle
after prolonged exposure to ultraviolet
lighting at the manufacturing facility
and at the user facility, resulting in
poor elongation properties and low
break points.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS --
CLASS II
_______________
PRODUCT (a) Bioproducts Baciferm 30 Medicated,
Bacitracin Zinc 30 g/lb, Type A
Medicated article, in 50 pound bags,
for use to increase rate of weight gain
and improve feed efficiency in
chickens, turkeys, cattle, and swine
and increase egg production and improve
feed efficiency in laying chickens.
Recall #V-031-3.
CODE 21124M23.
MANUFACTURER Bioproducts, Inc., Manson, Iowa.
RECALLED BY Bioproducts, Inc., Brecksville, Ohio,
by telephone March 26, 1993. Firm-
initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 46 bags were distributed.
REASON Product above the permitted assay
limits for bacitracin zinc.
_______________
PRODUCT Bioproducts brand Neo-Terramycin 10-5
Medicated Type B, in 10 pound bags,
OTC, used as an aid in the prevention
of various forms bacterial enteritis
and diarrhea.
Recall #V-032-3.
CODE 21030M19.
MANUFACTURER Bioproducts, Inc., Manson, Iowa.
RECALLED BY Bioproducts, Inc., Brecksville, Ohio,
by telephone March 11, 1993. Firm-
initiated recall complete.
DISTRIBUTION Missouri, Iowa.
QUANTITY 57 bales (5 10-pound bags per bale)
were distributed.
REASON Product below permitted assay limits
for neomycin.
_______________
PRODUCT Bio-tal (thiamylal sodium for
injection), in 1 gram and 5 gram
strengths, ultra-short-acting
thiobarbiturate anesthetic for use in
dogs, cats, swine, horses, and cattle,
sterile powder, Rx, for intravenous
administration. Recall #V-033-3.
CODE All lots.
MANUFACTURER Boehringer Ingelheim Animal Health,
Inc., St. Joseph, Missouri.
RECALLED BY Manufacturer, by letter June 2, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Australia, New Zealand,
Germany, Canada.
QUANTITY 813,037 units were distributed.
REASON Lack of sterility assurance.
SEIZURES:
=======================================================
_______________
PRODUCT Oxygen, USP (93-634-955/6).
CHARGE Adulterated - The methods used in, and
the facilities and controls used for,
the articles' processing, packing, and
holding do not conform to and are not
operated and administered in conformity
with current good manufacturing
practice requirements.
FIRM United Health Care Services, Inc.,
Philadelphia, Pennsylvania.
FILED June 15, 1993; U.S. District Court for
the Eastern
District of Pennsylvania; Civil
#93-3216; FDC #66703.
SEIZED June 16, 1993 - goods valued at
approximately $31,639.
_______________
PRODUCT Oxygen, USP (93-607-687).
CHARGE Adulterated - The methods used in, and
the facilities and
controls used for, the articles'
manufacture, processing,
packing, and holding do not conform to
and are not operated
and administered in conformity with
current good
manufacturing practice requirements.
FIRM United Health Care Services, Inc.,
Pittsburgh, Pennsylvania.
FILED June 15, 1993; U.S. District Court for
the Western District of Pennsylvania;
Civil #93-0951 FDC #66715.
SEIZED June 22, 1993 - goods valued at
approximately $20,567.
_______________
PRODUCT Various veterinary drug products
(93-636-092, et al.)
CHARGE New Animal Drugs - The articles are new
animal drugs because they are not
generally recognized by qualified
experts as safe and effective for their
intended uses, and they have not been
approved for marketing as required.
FIRM Immuno-Dynamics, Inc., Perry, Iowa.
FILED June 8, 1993; U.S. District Court for
the Southern District of Iowa, Central
Division; Civil #4-93-CV-80420;
FDC #66672.
SEIZED June 30, 1993 - goods valued at
approximately $41,000.
-8-
END OF ENFORCEMENT REPORT FOR JULY 14, 1993. BLANK
PAGES MAY FOLLOW.
####