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
01/15/1992
Recalls and Field Corrections: January 15, 1992
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Egg Crackers in 3 ounce cellophane bags. Recall #F-071-2.
Code: None.
Manufacturer: La Borinquena Bakery Corporation, Paterson, New Jersey.
Recalled by: Manufacturer, by telephone June 10, 1991. Firm-initiated
recall complete.
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Distribution: New York, New Jersey.
Quantity: Approximately 300 bags were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5 and has
artificial color substituted for eggs.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Epinephrine Injection, Rx, USP, 1:1000, in 1 ml tubex
cartridge units, sterile, 10 units per intermediate carton,
60 intermediate cartons per shipper carton, used in the
treatment of anaphylactic reactions, cardiac arrest,
allergic reactions, and asthma attacks. Recall #D-142-2.
Code: Lot numbers: 4897038, 4897039, 4897040, 4900013, 4900050,
4900051, 4900061, 4900119, 4900120, 4900121, 4900122,
4900123, 4900124, 4900125, 4900126, 4900127, 4900128,
4900129, 4900130, 4900162, 4900197, 4900198, 4900241,
4900439, 4900536. Packages may also carry the suffix "A".
Manufacturer: Wyeth-Ayerst Labs, Division of American Home Products,
Marietta, Pennsylvania.
Recalled by: Wyeth-Ayerst Labs., Division of American Home Products,
St. Davids, Pennsylvania, by media release December 13, 1991,
followed by letter December 16, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico, Norway, Sweden.
Quantity: 156,097 packages of 10 syringes each were distributed.
Reason: Subpotency.
----
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Product: Rite Aid brand Junior Strength Acetaminophen, grape
flavored chewable tablets, 24 tablets, 160 mg each, in
blister packaging on sleeves each containing 6 individual
tablets, an OTC drug product that provides fast, effective,
temporary relief of fever and discomfort due to colds and
flu. Recall #D-143-2.
Code: Lot #P7348 EXP 10/93.
Manufacturer: LNK International, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by telephone December 23, 1991, followed
by letter on or about December 30, 1991. Firm-initiated
recall ongoing.
Distribution: West Virginia, Florida, New York, South Carolina,
Pennsylvania.
Quantity: Approximately 480,000 tablets were distributed.
Reason: The unit carton label has a misprint regarding the
dosage for children 12-14 years.
----
Product: Recovered Plasma. Recall #B-082-2.
Code: Unit numbers: 56F85031, 56F85032, 56F85034, 56H73945,
56H73954, 56H73963, 56H74009, 56H74042, 56H74044, 56H74062,
56H74065, 56H74066, 56H74067, 56H74071, 56H74084, 56H74108.
Manufacturer: American Red Cross Blood Services, Syracuse, New York.
Recalled by: Manufacturer, by telephone August 24, 1990. Firm-initiated
recall complete.
Distribution: California.
Quantity: 16 units.
Reason: Recovered Plasma, untested for hepatitis B surface
antigen (HBsAg) and the antibody to human immunodeficiency
virus type 1 (anti-HIV-1), but labeled as nonreactive for
both markers, were distributed.
----
CORRECTION: Robitussin (Guaifenesin Syrup, USP), Expectorant,
8 ounces, and Robitussin DM, Cough Suppressant - Expectorant,
8 ounces, recalled by the Consumer Products Division of
A.H. Robins Company, Recall #D-089/090-2 which appeared in
the November 27, 1991 Enforcement Report incorrectly
included lot number 91-185-2 as a lot being recalled.
This lot is not being recalled.
----
Class III -
NONE
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
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Class II -
Product: Birtcher Electrosurgical Electrode Needle, sterile,
disposable. Recall #Z-119-2.
Code: Catalog #7-111, lot #9009-2001.
Manufacturer: Birtcher Medical Systems, Irvine, California.
Recalled by: Manufacturer, by telephone followed by letter April 13, 1990.
Firm-initiated recall complete.
Distribution: California, Illinois, Kentucky, Louisiana, Michigan,
Nebraska, New Hampshire, New York, Nevada, Oregon,
Pennsylvania, Texas, Washington state.
Quantity: 1,487 needles were distributed; firm estimates none
remains on the market.
Reason: A portion of this lot has compromised package seal
integrity thereby rendering the product unsterile.
----
Product: Aequitron Model LP6 and Model LP10 Volume Ventilators
containing defective Panasonic batteries, and batteries
from #1642 Preventative Maintenance Kits and #1603 Battery
Kits. The batteries are labeled in part, "Panasonic
Rechargeable Battery LCS-2912PL (12V, 2.9Ah/10HR). The
#1642 Preventative Maintenance Kits are labeled in part
"Reorder Model LP6 PM Kit". Recall #Z-204-2.
Code: Panasonic batteries with date codes 9012XX or 9101XX.
Manufacturer: Aequitron Medical, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter November 12 and 14, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Australia, Canada, Norway, Japan, Belgium,
New Zealand.
Quantity: 1,428 batteries were distributed.
Reason: Potential for corrosion on battery terminals could cause
ventilator failure.
----
Product: Marquest Medical Products, Inc., components, used in
various standard Marquest Medical Adult, Neonatal, and
Pediatric Volume Ventilator Circuits, as well as custom
configurations as follows:
(a) Disposable Adult Water Trap Assembly;
(b) Disposable Neonatal Water Trap Assembly;
(c) Adult Ventilator Circuits;
(d) Neonatal Ventilator Circuits;
(e) Pediatric Ventilator Circuits. Recall #Z-207/211-2.
Code: (a) Product codes 108509; all lots with lot numbers 54152
and below;
(b) Product codes 108501 and 108510; all lot numbers;
(c) Product codes: 090-078348, 090-095289, 090-098033,
090-098454, 090-098470, 090-098475, 090-098566, 090-098588,
090-098650, 090-098670, 090-098718, 090-098755, 090-098788,
090-098886, 090-098953, 090-098995, 090-099000, 090-099023,
090-099024, 090-099034, 090-099037, 090-099043, 090-1574042,
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090-1574075, 090-1574186, 090-093299, 090-095309, 090-108508,
090-157400, 090-157401, 090-157406, 090-326P, 090-091727,
090-095208, 090-095222, 090-095223, 090-095294, 090-095296,
090-098177, 090-099036, 090-157605, 090-157610, 090-157612,
090-095279, 090-093020; all lots with lot numbers 52841 and
below, and lot 900097 (includes custom configurations)
(d) Product codes: 090-082530, 090-082538, 090-091597,
090-091811, 090-091864, 090-091990, 090-092055, 090-092135,
090-092155, 090-092184, 090-092209, 090-092258, 090-092280,
090-092318, 090-092326, 090-092353, 090-092374, 090-092431,
090-092433, 090-092439, 090-092442, 090-092450, 090-092453,
090-092459, 090-092601, 090-092664, 090-092679, 090-092689,
090-092784, 090-092859, 090-092867, 090-098279, 090-092901,
090-092974, 090-092988, 090-098279, 090-098766, 090-108510,
090-155301, 090-155302, 090-155305, 090-155306, 090-155309,
090-1553107, 090-1553130, 090-1553152, 090-155312,
090-155402, 090-155503, 090-092581, all lots with lot
number 54576 and below (includes custom configurations);
(e) Product codes: 090-093064, 090-093080, 090-093099,
090-094019, 090-094059, 090-094074, 090-094078, 090-094090,
090-094104, 090-094105, 090-094107, 090-156300, 090-156305,
090-156310, 090-156355, 090-156500, 090-156505, 090-156510,
090-156520, 090-1574175, all lots with lot numbers 52605 and
below (includes custom configurations).
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by letter October 7, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Unknown.
Reason: Potential for water trap assembly leaks due to poor seals.
----
CORRECTION: Astra T Single Chamber Pulse Generators, manufactured
by Cardiac Pacemakers, Inc., St. Paul, Minnesota,
Recall #Z-147/148-2, which appeared in the January 2, 1992,
Enforcement Report should read:
Code: Model Number/Serial Number
0437 PG901538, PG901540-PG901544, PG901546,
PG901547, PG901900, PG901904-PG901909
0438 PG901545, PG901902, PG901903, PG910464
0439 PG901413-PG901422, PG901901, PG902118,
PG902119
0537 PG901187, PG901255-PG901257, PG901967
0538 PG091079, PG901219, PG901221-PG901223,
PG901266, PG091966, PG906552
0539 PG901078, PG901185, PG901186, PG901214,
PG901218, PG901220, PG901225, PG901227,
PG901253, PG901915, PG901916, PG902032,
PG904285, PG904581.
----
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Class III -
Product: In-vitro diagnostic kits and individually labeled reagents,
used for the detection of autoantibodies in human serum, or
individual containers of anti-human IgG conjugate/positive
controls used in the same type of tests:
(a) Speckled ANA Positive Control, product #PA2202;
(b) Anti-SS-A (Ro)/SS-B (la) Antibody test (this kit
contains Anti-SS-B (La) Positive Control lot #107A29);
The following kits containing Anti-Human IgG
(fluorescein labeled) Conjugate, (product code #PA2100,
catalog #2100), lot #108A05:
(c) Antinuclear Antibody (ANA) Test (HEp-2 cells);
(d) Anti-native DNA Antibody Test (Crithidia luciliae);
(e) Autoantibody Test System (Mouse Kidney/Stomach
Sections);
(f) Anti-Skin Antibody Test (Monkey/Guinea Pig Esophagus);
(g) Anti-Skin antibody Test (Monkey Esophagus Sections);
(h) Antinuclear Antibody (ANA) Test (Mouse Live Sections);
(i) AFT System I (This kit contains Anti-human IgG
conjugate (Fluorescein labeled) lot 106A34);
(j) AFT System I (This kit contains anti-human IgG
Conjugate (Fluorescein labeled) lot 107A19);
(k) AFT System I Reagent Package for Metpath (This lot
contains Anti-Human IgG Conjugate (fluorescein labeled)
lot 107A19);
(l) SS-A (Ro) Positive Control;
(m) SS-A (Ro)/SS-B (La) Positive Control;
(n) Anti-human IgG Conjugate (fluorescein labeled);
(o) RNP Positive Control. Recall #Z-156/170-2.
Code: Catalog No. Lot No.
(a) 2202 109A26
(b) 1109 109010
(c) 1102 108024, 109013
1103 109029
(d) 1106 108025, 109028
(e) 1107 108034
(f) 1104 110015
(g) 1105 108037, 110007
(h) 1100 109012
(i) 879011 M91052, M91057, M91058
(j) 879020 M91050, M91060, M91061
(k) MET101A M91051, M91059
(l) 600963 107020
(m) 600964 107021
(n) 20523 108027
(o) 21521 107012.
Manufacturer: IMMCO Diagnostics, Inc., Buffalo, New York.
Recalled by: Manufacturer, by telephone October 31, 1991, followed
by letter beginning November 4, 1991. Firm-initiated
recall ongoing.
Distribution: Maryland, New Jersey, Minnesota, Pennsylvania,
New York, Hong Kong, Switzerland, Canada.
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Quantity: (a) 1 vial; (b) 2 kits; (c) 11 kits; (d) Approx. 10 kits;
(e) 4 kits; (f) 2 kits; (g) 2 kits; (h) 2 kits;
(i) (48 tests) approx. 300 kits;
(j) (160 tests) approx 175 kits;
(k) 4 kits; (l) 415 vials; (m) 415 vials;
(n) 1 bulk 518 ml plasma pack;
(o) 1 bulk 85 ml plasma pack.
Reason: Products were manufactured with microbially contaminated
deionized water which could lead to reduced reactivity
with subsequent erroneous results.
----
Product: Blood collection tubes containing Heparin, tube size
64 x 10.25 mm, draw volume 3 ml, in boxes of 100 tubes;
(a) Item #6387 contains Sodium Heparin;
(b) Item #6388 contains Lithium Heparin.
Recall #Z-229/230-2.
Code: Lot numbers: (a) 0J021 EXP OCT92; (b) 0H238 EXP SEP92.
Manufacturer: Becton Dickinson Vacutainer Systems, Broken Bow, Nebraska.
Recalled by: Becton Dickinson Vacutainer Systems, Rutherford,
New Jersey, by letters mailed October 26-29, 1991.
Firm-initiated recall ongoing.
Distribution: (a) Nationwide and Canada; (b) Nationwide.
Quantity: (a) 7,810 boxes; (b) 5,950 boxes were distributed;
firm estimates less than (a) 1,500 boxes; (b) 500 boxes
remain on the market.
Reason: Tubes may break during use.
----
Product: Septi-Check Blood Culture Bottles for use in the
culture of microorganisms in blood, Cerebrospinal Synovial,
Pleural, or other body fluids and bone marrow aspirate:
(a) Septi-Check TSB/Columbia Blood Culture Bottles;
(b) Septi-Check BHI Blood Culture Bottles.
Recall #Z-231/232-2.
Code: (a) Item #43228, lot #52709-52611 EXP 3/22/93;
(b) Item #43551, lot numbers: 52402-03271 EXP 3/27/93,
52403-03281 EXP 3/28/93, 52404-04021 EXP 4/2/93,
52405-04031 EXP 4/3/93.
Manufacturer: Hoffmann-LaRoche AG, Germany.
Recalled by: Roche Diagnostic Systems, Inc., Montclair, New Jersey,
by letters of August 27, 1991, and September 16, 1991.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: (a) 3,150 cartons of 10 70-ml bottles;
(b) 7,143 cartons of 10 2-ml bottles were distributed;
firm estimates none remains on the market.
Reason: Some of the bottles may contain non-sterile media.
----
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Vitamin AD3/B12. Recall #V-012-2.
Code: Lot numbers: 2284, 2286, 2288, 2293, 2297, 2298,
2309, 2310, 2315, 2317, 2322, 2324, 2364, 2427, 2520,
2646, 2683, 2684.
Manufacturer: American Veterinary Products, Fort Collins, Colorado.
Recalled by: Manufacturer, by telephone November 18-25, 1991,
followed by letter December 10, 1991. Firm-initiated
recall ongoing.
Distribution: Missouri, California, New York, Texas, Iowa, New Mexico,
South Dakota, Colorado, Illinois, Nebraska, Puerto Rico.
Quantity: 26,132 units were distributed.
Reason: Product is degrading and falling below specification
for Vitamin A within 12 months. Product has a 24 month
expiration date with storage at room temperature.
----
Class III -
NONE
Injunction Actions Filed:
Against: Zenith Laboratories, Inc., Northvale, New Jersey.
Product: Generic Drug Products (91-613-529).
Charge: Adulterated - The methods used in, and the facilities or
controls used for, the products' manufacture,
processing, packing, and holding do not conform to and are
not operated and administered in conformity with current
good manufacturing practice regulations.
Filed: November 8, 1991 - U.S. District Court for the District
of New Jersey; Civil #91-4935(DRD), INJ #1256.
----
Against: Able Laboratories, Inc., South Plainfield, New Jersey.
Product: Generic Drug Products (91-613-667).
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Charge: Adulterated - The methods used in, and the facilities or
controls used for, the products' manufacture,
processing, packing, and holding do not conform to and are
not operated and administered in conformity with current
good manufacturing practice regulations.
Filed: November 6, 1991 - U.S. District Court for the District
of New Jersey; Civil #91-4916(AJL), INJ #1268.
----
Seizure Actions Filed:
Product: Various brands of rice (91-641-224).
Charge: Adulterated - One of the lots of rice contains insects
and bird feathers, and all of the lots of rice were
held under insanitary conditions whereby they may have
become contaminated with filth.
Firm: Kim Seng Trading Company, Inc., Los Angeles, California.
Filed: November 25, 1991 - U.S. District Court for the Central
District of California; Civil #91-6430, FDC #66304.
Seized: December 24, 1991, 10,000 pounds of rice valued at $5,000.
----
Product: Articles of drug (Catechin, Metox, Mycodicin, Hepasil,
Campycidin, and Osteocap) with accompanying literature
(91-591-923).
Charge: Products are unapproved new drugs.
Firm: Thorne Research, Inc., Sandpoint, Idaho.
Filed: November 19, 1991 - U.S. District Court for the District
of Idaho; Civil #91-0484 N HL4, FDC #66276.
Seized: December 18, 1991, various unapproved new drugs valued
at $24,231.
----
Product: Starkist brand Canned Tuna (91-624-947).
Charge: Adulterated - Product consists in part of a decomposed
substance.
Firm: H.J. Heinz Company, Tracy, California.
Filed: December 13, 1991 - U.S. District Court for the Eastern
District of California; Civil #91-551A, FDC #66302.
----
Product: Canned Tuna Fish Cat Food, relabeled as human food
(91-572-707).
Charge: Adulterated - Product consists in part of decomposed tuna
fish; and the product is pet food which had been relabeled
as human food, thus concealing its inferiority.
Firm: Gateway Foods, Minneapolis, Minnesota.
Filed: November 8, 1991 - U.S. District Court for the District
of Minnesota; Civil #4-91-890; FDC #66298.
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Seized: November 12, 1991, 162 cases valued at $4,300.
----
Product: Canned Tuna Fish Cat food, relabeled as human food
(91-363-861).
Charge: Adulterated - Product consists in part of decomposed tuna
fish; and the product is pet food which had been relabeled
as human food, thus concealing its inferiority.
Firm: Gateway Foods, LaCrosse, Wisconsin and Superior, Wisconsin.
Filed: November 12, 1991 - U.S. District Court for the Western
District of Wisconsin; Civil #91-C-960-S, FDC #66297.
Seized: November 26, 1991, 1,871 cases valued at $53,000 at
LaCrosse, Wisconsin. November 5, 1991, 280 cases valued at
$7,900 at Superior, Wisconsin.
----
Product: Amino Acid Tablets (91-626-792 et al).
Charge: Products are unapproved new drugs;
Misbranded - Products' labeling lacks adequate directions
for their safe and effective use.
Firm: Edom Laboratories, doing business as Consumer Vitamin
Values, Deer Park, New York.
Filed: August 29, 1991 - U.S. District Court for the Eastern
District of New York; Civil #91-CV-3337, FDC #66257.
Seized: September 5, 1991.
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