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
12/11/1991
Recalls and Field Corrections: December 11, 1991
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.
Product: New England Clam Chowder in 15 ounce cans, under the Snow's
brand and under a generic label. Recall #F-007-2.
Code: Top line of code reads: FEB 94, MAR 94, MAY 94, JUN 94,
JUL 94, and sencond line ends with "C".
Manufacturer: Borden Clam Products, Cape May, New Jersey.
Recalled by: Borden, Inc., Columbus, Ohio, by press release July 25,
1991, July 27, 1991, and July 31, 1991, followed by letter
July 31, 1991. Firm-initiated recall complete.
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Distribution: Maine, Vermont, New Hampshire, New York, Maryland,
Virginia, California, Nevada, Massachusetts, Connecticut,
Rhode Island, Pennsylvania, District of Columbia, Delaware,
Arizona, Florida, Canada, England (for codes FEB 94,
MAR 94). Chowder coded MAY 94, JUN 94, and JUL 94
was distributed only in New Jersey.
Quantity: Approximately 43,072 cases were distributed.
Reason: Product is underprocessed.
----
Product: RCV brand Unpasteurized Backfin Crabmeat, in 1 pound
plastic containers. Recall #F-051-2.
Code: Julian date 256 on bottom of carton.
Manufacturer: RCV Seafood Corporation, Morattico, Virginia.
Recalled by: Manufacturer, by telephone October 9, 1991. Firm-
initiated recall complete.
Distribution: Washington, D.C., Virginia.
Quantity: 164 pounds were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
----
Product: (a) Tuna, custom processed, in unlabeled 7.5 ounce cans;
(b) Sockeye Salmon, custom processed, in unlabeled 7.5
ounce cans. Recall #F-068/069-2.
Code: Lot numbers: (a) 83K01/L1691; (b) 83A01/1591 and
83A01/K2791.
Manufacturer: Clallam Custom Cannery, Inc., Clallam Bay, Washington.
Recalled by: Manufacturer, by telephone between October 1 and 14,
1991. Firm-initiated recall ongoing.
Distribution: Washington.
Quantity: (a) Approximately 320-350 cans; (b) 1,070 cans
were processed.
Reason: Product is underprocessed.
----
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: Ultra Slim Fast Strawberry Supreme Powder, in 15 ounce
cans, a high fiber formula, weight loss regimen.
Recall #F-064-2.
Code: Lot #OFUS 1268 B7.
Manufacturer: Olmark Packing Company, Franklin Park, Illinois.
Recalled by: Slim Fast Foods Company, New York, New York, by
telephone October 14, 1991, followed by letter October
15, 1991. Firm-initiated recall ongoing.
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Distribution: Nationwide.
Quantity: 3,806 cases (6 cans per case) were distributed.
Reason: Product is contaminated with salmonella.
----
Product: Sports Shot brand Lemon-Lime Flavored Non-Carbonated
Beverage, in 16 fluid ounce and 64 fluid ounce clear plastic
bottles. Recall #F-065-2.
Code: Lot numbers: All lots (16 ounce); JUL 11/92 and
earlier (64 ounce).
Manufacturer: Pace Dairy Foods Company, Cincinnati, Ohio (16 oz) and
Bluefield Beverage Company, Bluefield, Virginia (64 oz).
Recalled by: The Kroger Company, Cincinnati, Ohio, by letter dated
October 18, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and The Bahamas.
Quantity: 7,110 cases (24 16-ounce bottles per case) and
77,014 cases (8 64-ounce bottles per case) were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Swiss Mix, Ann's House of Nuts Brand, 16 and 12 ounce
packages, and in 25 pound cartons. Product consists
of mixture of nuts, candies and dried fruit.
Recall #F-040-2.
Code: Julian date of manufacture codes 066, 073, 080, 086, 095,
101, 119, 135, 154, 170, 196, 205 with pull dates in 1991.
Manufacturer: Ann's House of Nuts, Inc., Rockville, Maryland.
Recalled by: Manufacturer, by visit. Firm-initiated recall ongoing.
Distribution: Washington, D.C., Maryland, Virginia, Pennsylvania,
New Jersey, Ohio, Indiana, Florida, Michigan, New York.
Quantity: 822 cases (24 16-oz packages each), 2,618 cases
(24 12-oz packages each), and 48 cases (25 pounds each)
were distributed.
Reason: Product fails to declare appropriate artificial color.
----
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Product: Eight varieties of cakes and cookies in 2 ounce packages,
90 cakes/cookies per case:
(a) Chocolate Chip Cookies;
(b) Peanut Butter Cookies;
(c) Hawaiian Banana Pecan Cakes;
(d) Jamaican Spice Cakes;
(e) Swiss Fudge Chocolate Cakes;
(f) Dutch Chocolate Chocolate Chunk Cakes;
(g) French Vanilla Cakes;
(h) Oatmeal Cookies. Recall #F-056/063-2.
Code: Best used by dates: 11/14/90, 11/18/90, 11/19/90,
11/20/90, 11/21/90, 11/29/90, 12/4/90, 12/5/90.
Manufacturer: All-Star Foods, Inc., Schaumburg, Illinois.
Recalled by: Lifestyles U.S.A., Chesterfield, Missouri, by telephone
June 1990. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: Unknown.
Reason: Product is contaminated with mold.
----
Product: Cadbury Milk Chocolate Fund Raiser Candy bars:
(a) Cadbury Roast Almond Bars. 2.2 ounces;
(b) Cadbury Krisp Bars, 2.2 ounces. Recall #F-066/067-2.
Code: (a) Item #03746; (b) Item #03750.
Manufacturer: Hershey Chocolate U.S.A., Hazelton, Pennsylvania.
Recalled by: Hershey Chocolate U.S.A., Hershey, Pennsylvania, by
letter October 24, 1991. Firm-initiated recall ongoing.
Distribution: Pennsylvania.
Quantity: (a) 65,908 cases (30 bars per case); (b) 84,424 cases
(30 bars per case) were distributed.
Reason: Product contains plastic fragments.
----
Product: Ice Mountain Spring Water, in 1 gallon and 2.5 gallon
bottles. Recall #F-070-2.
Code: Lot numbers: 080791, 080891, 082191, which represent
the bottling dates of 8/7/91, 8/8/91, and 8/21/91.
Manufacturer: Poland Spring Bottling Company, Poland Spring, Maine.
Recalled by: The Perrier Group of America, Greenwich, Connecticut,
by interoffice instruction October 16, 1991. Firm-initiated
recall ongoing.
Distribution: Maine, New Hamsphire, Massachusetts, Connecticut,
Rhode Island.
Quantity: 69,072 1-gallon bottles and 22,645 2.5-gallon bottles were
distributed.
Reason: Product is contaminated with sand.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Potassium Chloride Injection USP (2mEq K+/mL) in clear
glass bottle, 500 ml;
(b) 5% Sodium Chloride Injection USP Hypertonic in clear
glass bottle, 500 ml. Recall #D-098/099-2.
Code: Lot Numbers: (a) J1B063, J1J016; (b) J1C010.
Manufacturer: McGaw, Inc., Irvine, California.
Recalled by: Manufacturer, by letter September 9, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide, Hong Kong, Saudi Arabia.
Quantity: (a) 7,092 units; (b) 4,272 units were distributed.
Reason: pH above USP specification.
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Product: Betamethasone Valerate Cream USP, 0.1%, in 15 and
45 gram metal tubes, a Rx topical corticosteroid
for dermatologic use, under CPL, Goldline, Bioline,
Qualitest and URL labels. Recall #D-101-2.
Code: All lots.
Manufacturer: Clay Park Labs, Inc., Bronx, New York.
Recalled by: Manufacturer, by letter November 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Undetermined.
Reason: The product may have microbial and/or fungal contamination.
----
Product: Betamethasone Dipropionate Cream USP, 0.05%, in
15 and 45 gram tubes, a Rx topical adrenocorticosteroid
for dermatologic use, under CPL, Goldline and Syosset
labels. Recall #D-102-2.
Code: Lot #L767 EXP 1/93.
Manufacturer: Clay Park Labs, Inc., Bronx, New York.
Recalled by: Manufacturer, by letter October 18, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 4,063 15-gram tubes and 1,210 45-gram tubes were distributed.
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Reason: The product may have microbial and/or fungal contamination.
----
Class III -
Product: Paraldehyde, USP, in 30 ml bottles, a Rx product in liquid
form used therapeutically as a hypnotic. Recall #D-097-2.
Code: Lot numbers 19011 and 19012 EXP 5/93.
Manufacturer: Lonza, Inc., Fairlawn, New Jersey.
Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by
telephone between February 28, 1991 and March 3, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 7,090 bottles were distributed.
Reason: Product does not meet all USP specifications.
----
Product: Derma-Smoothe/FS Topical Rx oil indicated for the
treatment of atopic eczema, in 4 ounce plastic bottles.
Recall #D-100-2.
Code: Lot numbers: E900009/10, F900011/12, F900014/15,
G900018, H900019, J900025, K9000000027/29, L900030,
A910001, A910003/4, B910005/6, D910008/9, E910011,
F910012, G910018.
Manufacturer: Hill Dermaceuticals, Inc., Orlando, Florida.
Recalled by: Manufacturer, by letter June 18, 1991 and August 12, 1991.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: Approximately 207,047 bottles were distributed.
Reason: Subpotency.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Body Side Wafers, a two-piece unit, with third optional
piece, attach to body surrounding stoma for urostomy, three
brand names using two flange types:
(a) Sur-Fit Wafer, original Sur-Fit system wafer
designed to fit Surfit bagside flange, uses a System II
flange;
(b) Sur-Fit Flexible Wafer, uses a System IV Sur-Fit flange,
also called low profile;
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(c) Durahesive Wafer - uses a System IV, low profile flange;
(d) Urostomy Pouch (bag), designed to contain fluid resultant
from urostomy. Uses only Sur-Fit bagside Flange, which
accepts both the System II and system IV bodyside flanges;
(e) Convex Insert (optional), can be inserted into the
bodyside flange to create a curvature in the bodyside
wafer to allow for better contact with the stoma.
Recall #Z-131/135-2.
Code: ConvaTec Standary Sytle Urostomy Pouch
List number Control number
24231 OEX2809, OFX2834
24232 OFX2802
24233 OEX2903, OFX2836, OFX2803
24235 ODX2832, OFX2838
24236 ODX2837, ODX2805
ConvaTec Accuseal Urostomy Pouches
21926 OEX2811, OGX2814, ODX2830
21927 9BX2844, OGX2811, 9MX2814, OGX2825
21928 OEX2804, OGX2815, OEX2815, OBX2824
21936 OBX2800, ODX2829, OFX2826,
21937 OEX2816, OGX2804, OGX2828, OBX2821
21956 OEX2806, OBX2833, 9LX2810
21957 OEX2817, 9MX2833, OBX2811
21958 OCX2814, 9CS2815
21938 OCX2812, OFX2830, OEX2822, 9MV2810.
Manufacturer: ConvaTec, Ltd., Whales, United Kingdom, and Medispo APS,
Denmark (flange).
Recalled by: ConvaTec, (a Bristol-Myers Company) Skillman, New Jersey,
by memorandum August 24, 1990, and September 4, 1990.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 56,513 units were distributed; firm estimates none
remains on the market.
Reason: The narrowing of the channel width of the pouchside flange
has compromised the binding strength of the flange-to-flange
connection resulting in urine leakage.
----
Product: Calcitek brand Hydroxylapatite coated endosseoous dental
implant body with healing screw, 13 mm long and 4 mm
diameter. Recall #Z-137-2.
Code: Lot number 910589.
Manufacturer: Calcitek, Carlsbad, California.
Recalled by: Manufacturer, by telephone March 19, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 114 units were distributed.
Reason: The inner product labeling incorrectly identifies the
product as 8 mm in length.
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Product: Polysafe A-Trac Endocardial Ventricular Implantable
Pacing Leads used with SAVVI Model 305 Pacemakers:
(a) Model AT-133; (b) Model AT-134; (c) Model AT-332;
(d) Model AT-333; (e) Model AT-334. Recall #Z-138/142-2.
Code: All serial numbers.
Manufacturer: Cardiac Control Systems, Inc., Palm Coast, Florida.
Recalled by: Manufacturer, by letter August 16, 1991. Firm-initiated
recall ongoing.
Distribution: Florida, Tennessee, Massachusetts, New Hampshire, Maine,
Connecticut, New Jersey, New York, Pennsylvania, Louisiana,
Texas, California, Oklahoma, Missouri, France, United
Kingdom, Turkey, Hong Kong, Japan.
Reason: Patients with the above lead/pacemaker combination may
experience patient mediated tachycardia (PMT), resulting
from electrical crosstalk within the lead's connector,
and indicated by an afterpotential artifact in the atrial
sense channel following the associated ventricular pacing.
----
Product: MCRT X-Ray Generator System. Recall #Z-143-2.
Code: All serial numbers.
Manufacturer: Philips Medical Systems, Inc., Shelton, Connecticut.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan November 18, 1991. Firm-initiated field correction
complete.
Distribution: Nationwide.
Quantity: 160 units were distributed.
Reason: Noncompliance with performance standard for x-ray
products in that the generator could produce unintiated
and unrequested fluoroscopic exposures.
----
Product: Skyland Bacillus Pumilus Biological Indicator Sporestrips.
Recall #Z-144-2.
Code: Lot numbers: 301221, 310641.
Manufacturer: Skyland Scientific Services, Inc., Bozeman, Montana.
Recalled by: Manufacturer, by telephone October 11-15, 1991, followed
by letter October 16, 1991. Firm-initiated recall ongoing.
Distribution: New Jersey, California, Texas, Colorado, North Carolina,
New York, Massachusetts, Connecticut, Oregon, Wisconsin,
Rhode Island, Maryland, Pennsylvania, Washington state,
Kentucky, Ohio, Puerto Rico, Canada, Germany.
Quantity: 41,200 units were distributed.
Reason: The device apparently has been marketed without an
approved 510(k) Premarket Notification.
----
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Class III -
Product: Difco Rubella-Cube Test Kit, Product #5440-24-9, an
enzyme immunoassay for the qualitative detection of rubella
virus specific antibody (IgG) to aid in the determination of
an individual immune status to the virus. Recall #Z-145-2.
Code: Lot #795327 EXP 5/1/92.
Manufacturer: V-Tech, Inc., El Monte, California.
Recalled by: Difco Laboratories, Inc., Livonia, Michigan, by letter
August 8, 1991. Firm-initiated recall ongoing.
Distribution: Texas, Pennsylvania, Mississippi, Wisconsin, Louisiana,
Canada, Mexico, Italy.
Qantity: 155 kits were distributed.
Reason: The product appears to have lost potency prior to the
expiration date and is not detecting low levels of antibody.
----
Product: Rheumatoid Factor (RF) Test Kit, an in-vitro diagnostic
Class II medical device used to quantitatively and
qualitatively measure rheumatoid factor in the human serum:
(a) Kit Control #789722 EXP 9/30/91;
(b) Kit Control #790736 EXP 9/91;
(c) Kit Control #795381 EXP 12/91;
(d) Kit Control #796633 EXP 12/91. Recall #Z-171/174-2.
Code: All kits with Difco item #3241-32-5. Reagent control
numbers are the same as the control number assigned to the
kit.
Manufacturer: V-Tech, Inc., Diagnostic Facility, El Monte, California.
Recalled by: Difco Laboratories, Inc., Livonia, Michigan, by
letter September 27, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Europe.
Quantity: (a) 90 kits; (b) 23 kits; (c) 80 kits; (d) 6 kits
were distributed.
Reason: The expiration date was improperly extended.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: (a) Crysticillin 300 A.S., Sterile Penicillin G Procaine
suspension, in 100 and 240 ml vials, distributed by Solvay
Veterinary;
(b) Pen-Aqueous, Penicillin G Procaine Aqueous Suspension,
manufactured for Rx Veterinary Products;
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(c) Sterile Penicillin G Benzathine and Penicillin G
Procaine in Aqueous Suspension, in 250 and 100 ml vials,
manufactured for Rx Veterinary Products, Burns Vet Supply,
and Fermenta Animal Health Company. Recall #V-009/011-2.
Code: Lot numbers: (a) 9F24505 EXP JUN 1 92, 9J24545 EXP SEP 1 92,
9J24529 EXP SEP 1 92 (100 ml), 9F24515 EXP JUN 1 92,
9J24520 EXP SEP 1 92, 9J24539 EXP SEP 1 92,
9J24507 EXP SEP 1 92, 9J24563 EXP SEP 1 92 (240 ml);
(b) H1506 EXP SEP 91; (c) H1503 EXP SEP 91 (250 ml),
H1393 EXP SEP 91 (100 ml).
Manufacturer: G.C. Hanford Manufacturing Company, Syracuse, New York.
Recalled by: Manufacturer, by letter September 10, 1991. Firm-
initiated recall ongoing.
Distribution: Minnesota, Missouri, New York, Kansas.
Quantity: (a) 65,702 vials (250 ml), 113,237 vials (100 ml);
(b) 5,526 vials; (c) 11,584 vials (250 ml),
28,278 vials (100 ml) were distributed.
Reason: Lack of sterility assurance.
----
Class III -
NONE
Injunction Action Filed:
Against: Jeong C. Choi, an individual, doing business as
Han Yang Oriental Food Manufacturing, Tacoma, Washington.
Product: Tofu (91-6969-201 et al).
Charge: Products consisted in whole or in part of a filthy
substance, and were held under insanitary conditions
whereby they may have become contaminated by filth.
Filed: November 15, 1991 - U.S. District Court for the Western
District of Washington; Civil #C91-5473, INJ #1269.
----
Against: Edward Fine, an individual, and Biopharmaceutics, Inc.,
a drug manufacturer, Bellport, New York.
Product: Pharmatrex Cold Tablets (90-601-392).
Charge: Products were not prepared in conformance with current
good manufacturing practice regulations and the safety and
the identity and strength may not meet the quality and
purity characteristics purported or which they are
represented to possess.
Filed: November 20, 1991 - U.S. District Court for the Southern
District of New York; Civil #CV-91-3936, INJ #1236.
Disposition: Consent degree of permanent injunction restraining the
corporation and its president from distributing drugs
that are not made in compliance with current good
manufacturing practices.
----
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Seizure Actions Filed:
Product: Contact Lenses (91-533-429 et al).
Charge: Products are Class III devices which do not have in
effect the required approved premarket application;
labels do not bear the name and address of the
manufacturer or adequate instructions and directions for use
since such instructions and directions cannot be written for
devices with expired dates.
Firm: N & N Contact Lens International, Inc., Bothell, Washington.
Filed: May 15, 1991 - U. S. District Court for the Western
District of Washington; Civil #C91-674, FDC #66088.
----
Product: Sterilant Solutions (91-474-598).
Charge: The solutions are Class III devices which do not
have in effect the required approved premarket
applications; labeling and accompanying literature for
the devices represent that the products are capable of
killing a variety of the microbes, including HIV-1, the
virus which causes AIDS.
Firm: Metrex Research Corporation, Parker, Colorado.
Filed: November 19, 1991 - U.S. District Court for the
District of Colorado; Civil #91-B-2019, FDC #66179.
----
Product: Herbal Remedies (91-452-764).
Charge: Misbranded - Products are unapproved new drugs.
Firm: HMS-Pep, Castle Rock, Colorado.
Filed: November 19, 1991 - U.S. District Court for the
District of Colorado; Civil #91-N-2018, FDC #66273.
----
Product: DEFEND! Antimicrobial Liquid Soap and Alcohol Gel
(91-528-059/60).
Charge: Products are new drugs without approved New Drug
Applications; labeling fails to bear adequate directions
for use and they are not exempt from this requirement.
Firm: Origi-Nails, Inc., Arlington, Texas.
Filed: October 22, 1991 and November 7, 1991 (amended) -
U.S. District Court for the Northern District of Texas,
Fort Worth Division; Civil #4-91-737-A, FDC #66256.
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