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
07/13/1994
Recalls and Field Corrections: Foods -- Class I -- 07/13/1994
July 13, 1994 94-28
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Ice cream in 3 gallon bulk containers in the following
flavors: (a) Tin Roof Sundae; (b) M & M Pieces; (c)
Snicker's. Recall #F-715/717-4.
CODE None.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania,
by letter March 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY (a) 41 containers; (b) 114 containers; (c) 308 containers
were distributed.
REASON Products contain peanuts and peanuts are not declared on the
label.
_______________
PRODUCT Solid White Tuna, in 6-1/8 ounce metal cans, in shrink
wrapped packages of 4 or 6 cans. Recall #F-718-4.
CODE All cluster packs sold in Alaska, Arizona, California,
Colorado, Hawaii, Idaho, Iowa, Kansas, Missouri, Montana,
Nebraska, Nevada, New Mexico, Oregon, Texas, Utah,
Washington state, Wyoming.
MANUFACTURER Devoe and Company, Los Angeles (repacker).
RECALLED BY Bumble Bee Seafoods, Inc., San Diego, California, by letter
and press release March 25, 1994. Firm-initiated recall
complete.
DISTRIBUTION Alaska, Arizona, California, Colorado, Hawaii, Idaho, Iowa,
Kansas, Missouri, Montana, Nebraska, Nevada, New Mexico,
Oregon, Texas, Utah, Washington state, Wyoming.
QUANTITY 31,158 trays (48 cans per tray) were distributed.
REASON Product in punctured or cut cans has the potential to become
contaminated with Clostridium botulinum bacteria or spores
with subsequent production of neurotoxin.
_______________
PRODUCT Various sandwiches: (a) Hot Ham and Cheese; (b) Bologna and
Cheese; (c) Ham and Swiss on Rye; (d) Ham on Rye.
Recall #F-719/722-4.
CODE Sell by dates: (a) 2/16/94, 3/9/94, 3/15/94; (b) 2/9/94;
(c) 2/21/94, 3/14/94; (d) 3/28/94.
MANUFACTURER One Stop Deli, Inc., Edinburg, Virginia.
RECALLED BY Manufacturer, by visit beginning January 22, 1994. Firm-
initiated recall complete.
DISTRIBUTION Virginia, West Virginia, Maryland, Washington, D.C., North
Carolina, Delaware, Pennsylvania.
QUANTITY (a) 2,595 sandwiches (sell by 2/16/94), 1,453 sandwiches
(sell by 3/9/94), 2,955 sandwiches (sell by 3/15/94);
(b) 2,096 sandwiches; (c) 3,595 sandwiches (sell by
2/21/94), 2,885 sandwiches (sell by 3/14/94); (d) 3,120
sandwiches were distributed.
REASON Products are contaminated with Listeria monocytogenes.
_______________
PRODUCT Axler's Cream Cheese and Lox Spread, in 8 ounce and 5 pound
containers. Recall #F-723-4.
CODE Case coded 6 3 94.
MANUFACTURER Springfield Smoked Fish Company, Inc., Springfield,
Massachusetts.
RECALLED BY Manufacturer, by telephone May 11, 1994. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts, Connecticut, Georgia.
QUANTITY 20 pounds.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Uncle's Ben's Converted Rice, in 3 pound bags.
Recall #F-385-4.
CODE 008041, 100294 FEB 1996.
MANUFACTURER Effem Productos Alimenticios, El Dorado Do Sul, Brazil.
RECALLED BY Master Foods Interamerican, Bayamon, Puerto Rico, by visit
May 1994. Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY 1,038 cases (12 bags per case) were distributed.
REASON Product contains the pesticide Fenitrothion.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Levothroid Tablets (levothyroxine sodium tablets, USP), 100
mcg, packaged in 100 tablet bottles, Rx for the replacement
or substitution therapy for diminished or absent thyroid
function. Recall #D-322-4.
CODE Lot #FP0316 EXP 2/95.
MANUFACTURER Rhone Poulenc Rohrer, Manati, Puerto Rico.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter
June 20, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 29,774 bottles were distributed.
REASON Subpotency.
_______________
PRODUCT Doxycycline Hyclate Capsules, USP, 100 mg, in bottles of
500, Rx broad spectrum antibiotic, under the Schein
Pharmaceuticals label. Recall #D-323-4.
CODE Lot numbers: 08375C EXP 2/95, 08374C EXP 2/95,
08376C EXP 3/95.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Danbury Pharmacal, Inc., Brewster, New York, by letter June
14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,909 bottles of lot 08375C, 1,983 bottles of lot 08374C,
and 1,944 bottles of lot 08376C were distributed.
REASON Lot 08375C does not meet dissolution specifications. Lots
08374C and 08376C lack assurance of meeting dissolution
specifications through expiration date.
_______________
PRODUCT Diphenhydramine Hydrochloride Capsules USP, 50 mg, packed in
unit dose blister packs, Rx with the following indications,
antihistaminic, motion sickness and antiparkinsonism.
Recall #D-324-4.
CODE Lot #628-9 EXP 10/95.
MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia,
Pennsylvania.
RECALLED BY Auro Pharmaceuticals, Inc., Williamsville, New York
(repacker/responsible firm), by telephone June 30, 1994,
followed by letter July 1, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Louisiana, Massachusetts, New York.
QUANTITY 956 boxes (100 capsules per box) were distributed between
2/17/94 and 5/27/94; firm estimates 50% of product remains
on the market.
REASON Presence of particles of amitriptyline resulting from
repacking operation.
-3- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Anti-Gas Colic Drops, in 1 fluid ounce bottles.
Recall #D-320-4.
CODE Lot #AB03 EXP 1/95.
MANUFACTURER RSR Laboratories, Inc., Bristol, Tennessee.
RECALLED BY Reinhard Laboratories, Inc., Richmond, Virginia (responsible
firm), by verbal contact. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY 72 bottles were distributed.
REASON Incorrect dosage statement on carton. Label has correct
declaration.
_______________
PRODUCT Avon Sun Seekers Sunblock Lotion SPF-15, in 4 fluid ounce
bottles, used for sunburn protection. Recall #D-321-4.
CODE Lot numbers: 41114 and 41124.
MANUFACTURER Avon Products, Inc., Morton Grove, Illinois.
RECALLED BY Avon Products, Inc., New York, New York, by undated letter
sent May 27, 1994, and by letter dated May 24, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24,286 bottles were distributed.
REASON Bottles labeled SPF-15 contained SPF-4 lotion.
_______________
PRODUCT Demerol Hydrochloride 5% (Meperidine HCl injection, USP), 25
mg and 50 mg, a narcotic analgesic for the relief of
moderate to severe pain. Recall #D-325/326-4.
CODE Lot #M045LD EXP 4/99.
MANUFACTURER Sanofi Winthrop Pharmaceuticals, Inc., McPherson, Kansas.
RECALLED BY Sterling Winthrop, Inc., New York, New York, by telephone
June 9 & 10, 1994, and by letter June 20, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Delaware, Georgia, California.
QUANTITY 1,104 boxes (25 ampules per box) were distributed.
REASON Some 25 mg ampuls were packed in cartons labeled 50 mg.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Liquid Plasma.
Recall #B-306/307-4.
CODE Unit #P42558.
MANUFACTURER Sacramento Medical Foundation, Sacramento, California.
RECALLED BY Manufacturer, by telephone February 10, 1992. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component.
-4- REASON Autologous blood products, which tested repeatedly reactive
for hepatitis B surface antigen (HBsAg) and to the antibody
for hepatitis B core antigen (anti-HBc), were distributed
without the "Biohazard" label on the containers.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Sterile Single-Use Disposable Infusion Pumps,
Infusion/Administration Sets & Reservoir Bags:
(a) 160-42-40 Mini-Vol Infusion Set;
(b) 53-60-35 Low-Vol Extension Set;
(c) 53-60-40 Mini-Vol Extension Set;
(d) 53-60-40C Mini-Vol Extension Set;
(e) 53-90-35 Low-Vol Extension Set;
(f) BF-13 Bifuse Administration Set;
(g) BF-78 Bifuse Administration Set;
(h) BR-10 Benzing Retrograde Administration Set;
(i) FS-116 Filter Administration Set;
(j) IFH-20 Infusion Set;
(k) IPR-250 Reservoir Bag;
(l) IPR-86 Reservoir Bag;
(m) PP-05 Pump Set;
(n) TE-300 Triplet Connector Set;
(o) TR-78 Trifuse Administration Set;
(p) PS0400/300 Pump Tubing Set. Recall #Z-1059/1074.
CODE Lot numbers: (a) MF93015; (b) MF93059, MF93078, MF93082,
MF93089, MF93114, MF93120, MF93130;
(c) MF93062, MF93077, MF93085 & MF93100; (d) MF93099;
(e) MF93038; (f) MF93066; (g) MF93086;
(h) MF93064; (i) MF93105; (j) MF92357, MF93026;
(k) MF93044K, MNF93079K; (l) MF93090K;
(m) MF93088; (n) MF93124; (o) MF93084; (p) MF93097.
MANUFACTURER Medex, Inc., Duluth, Georgia.
RECALLED BY Manufacturer, by letter in May and June 11, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, United Kingdom.
QUANTITY Approximately 107,000 units.
REASON Some of the Tyvek packaging seals may be weak or possibly
open, thereby compromising the sterility of the devices.
_______________
PRODUCT Pikos 01, unipolar/bipolar multiprogrammable implantable
pulse generator. Recall #Z-1075-4.
CODE Noncontinuous serial numbers 8341165, 83440523 through
83520902.
MANUFACTURER Biotronik GmbH & Company, Berlin, Germany.
RECALLED BY Biotronik, Inc., Lake Oswego, Oregon, by visit. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
-5- QUANTITY 154 units.
REASON The device experienced in some cases loss of telemetry due
to an out-of specification resistance on an integrated
circuit component.
_______________
PRODUCT Soft Contact Lens: (a) NewVues (Vifilcon A) Clear, Part
#394162; (b) Focus Toric (Vifilcon A), Part #200238.
Recall #Z-1076/1077-4.
CODE Lot numbers: (a) 3177020; (b) 3150750.
MANUFACTURER Ciba Vision Corporation, Duluth, Georgia.
RECALLED BY Manufacturer, by letter May 13, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Switzerland, Germany, Canada.
QUANTITY (a) 1,153 (6 lens multipacks); (b) 43 (6 lens multipacks)
were distributed.
REASON Products may be labeled with incorrect sphere power which
may result in inability to see out of lens.
_______________
PRODUCT Alcon Eye Drapes, used for ophthalmic surgery:
(a) Part #8065-1030-99 with an oval aperture cut into the
drape that gives direct access to the eye;
Part #8065-1031-99, with a clear plastic incise area that
covers the eye, requiring the surgeon to cut a hole in the
incise area. Recall #Z-1081/1082-4.
CODE Lot number range 92306 through 96077.
MANUFACTURER Alcon Surgical, Houston, Texas (custom pack kits);
Haywood Vocational Opportunities, Hazelwood, North Carolina
(eye drape).
RECALLED BY Alcon Laboratories, Inc., Fort Worth, Texas, by telephone
between April 15 and 25, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 4,329 units distributed between 2/23/94 and 4/25/94.
REASON There is a potential for ink flaking from the imprinted logo
to the plastic eye area of the drape.
SEIZURES:
=================================================================
_______________
PRODUCT Canned Sardines (93-682-697/8).
CHARGE Adulterated - The articles contain an added poisonous or
deleterious substance, lead, which may render them injurious
to health.
LOCATION Grimes Distribution Services, Jacksonville, Florida.
FILED April 5, 1994; U.S. District Court for the Middle District
of Florida, Jacksonville Division; Civil #94-328-CIV-J-20;
FDC #66932.
SEIZED April 7, 1994 - goods valued at approximately $26,880.
-6- _______________
PRODUCT Frozen Peeled Shrimp (93-682-242).
CHARGE Adulterated - The article consists in whole or in part of
decomposed shrimp.
LOCATION National Freezers, Inc., Miami, Florida.
FILED April 22, 1994; U.S. District Court for the Southern
District of Florida, Pensacola Division; Civil #94-0701-CIV-
GRAHAM; FDC #66938.
SEIZED May 4, 1994 - goods valued at approximately $86,000.
_______________
PRODUCT Frozen Halibut Steaks (94-630-113/4).
CHARGE Adulterated - The articles consist in part of a decomposed
substance by reason of the presence of decomposed fish.
LOCATION Cityice Cold Storage Company, Seattle, Washington.
FILED April 14, 1994; U.S. District Court for the Western District
of Washington; Civil #C94-578Z; FDC #66952.
SEIZED May 3, 1994 - goods valued at approximately $33,350.
_______________
PRODUCT Articles of over-the-counter skin products in retail
packages and bulk drums (93-660-001, et al).
CHARGES New drugs - The articles are not generally recognized by
qualified experts as safe and effective for their intended
uses and there are no approved applications in effect.
Misbranded - Some of the articles' labeling fails to bear
the established name of each active ingredient; and all of
the articles' labeling fails to bear adequate directions for
use.
LOCATION Low Pharmaceuticals, Inc., Wallingford, Connecticut.
FILED May 19, 1994; U.S. District Court for the District
of Connecticut; Civil #394CV00813; FDC #66787.
SEIZED June 10, 1994 - goods valued at approximately $430,830.
MASS SEIZURE:
=============================================================
_______________
PRODUCTS Various articles of drug, in various sizes and types of
containers (regardless of identification as to lot, batch,
part, or control number) variously labeled or unlabeled,
which are determined to have originated outside the State of
Texas, and which are identified as, or otherwise determined
to consist of, one or more of the following: Albuterol
Sulfate, Cephalexin Monohydrate, Conjugated Estrogen,
Cromolyn Sodium, Desipramine Hydrochloride, Indomethacin,
Ipratropium Bromide, Isoetharine Hydrochloride, Ketoprofen,
Metaproterenol Sulfate, Methotrexate, Methoxsalen, Morphine
Sulfate, Nifedipine, Phenytoin, Piroxicam, Sulfapyridine,
Tetracycline, Vancomycin Hydrochloride, Warfarin (92-451-
954, et al.)
-7- CHARGES Misbranded - The articles of drug, Cephalexin Monohydrate,
Tetracycline, and Vancomycin Hydrochloride, are antibiotics
that are not certified as required and they are not exempt
from such certification requirements because they are not
the subject of an approved antibiotic drug application or an
approved abbreviated antibiotic drug application. The
remaining articles' labeling fails to bear adequate
directions for use. The articles are intended for
processing, repacking, or use in the manufacture of other
drugs, or are sold as prescription chemicals for use by
registered pharmacists in compounding prescriptions or for
dispensing upon prescriptions, but these articles are not
exempt because the drug products that result from use of the
articles are new drugs and no new drug applications have
been approved for any of these drugs as required.
LOCATION Professional Compounding Centers of America, Inc., Houston,
Texas.
FILED June 21, 1994; U.S. District Court for the Southern District
of Texas, Houston Division; Civil #H94-2116; FDC #66451.
SEIZED June 22, 1994 - goods valued at approximately $503,000
(actual cost), with a potential value of $2,286,000.
-8-
END OF ENFORCEMENT REPORT FOR JULY 13, 1994. BLANK PAGES MAY FOLLOW.
####