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
06/16/1993
Recalls and Field Corrections: Foods -- Class II -- 06/16/1993
June 16, 1993 93-24
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
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PRODUCT Solo Banana Soda, in 12 ounce glass bottles.
Recall #F-450-3.
CODE All lots.
MANUFACTURER Brooklyn Bottling Corporation, Brooklyn, New York.
RECALLED BY Manufacturer, by letter on or about April 26, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 636 cases were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Heart Smart Non-Dairy Creamer, in 12 ounce cardboard
containers. Recall #F-451-3.
CODE All lots.
MANUFACTURER Mark Lynn Industries, Inc., Bremen, Georgia.
RECALLED BY Manufacturer, by visit March 17, 1993. Firm-initiated
recall complete.
DISTRIBUTION South Carolina.
QUANTITY 423 cases (24 canisters per case) were distributed.
REASON Product is was contaminated with metal shavings.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=======================
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PRODUCT Leather Jacket Fillets, frozen, packed in bulk cartons of
15kg (33 pounds) per carton. Recall #F-449-3.
CODE None.
MANUFACTURER Allied Hock Bee (Canada) Ltd., Ontario, Canada (importer).
RECALLED BY Giant Food Stores, Inc., Carlisle, Pennsylvania, by
electronic mail May 7, 1993. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY 3,201 pounds were distributed.
REASON Product is decomposed.
_______________
PRODUCT Olive Oils, various types and brands including:
1. Rubino Extra Virgin, 1 gallon can
2. Rubino 100% Pure, 1 gallon can
3. Rubino Pomace, 1 gallon can
4. Rubino Pomace 190 kg. drum
5. Rubino 25% Olive Oil & Canola Blend, 1 gallon jug
6. Rubino 10% Olive Oil & Canola Blend, 1 gallon jug
7. Rubino 50% Olive Oil & Canola Blend, 1 gallon jug
8. Regale Extra Virgin, 1 gallon can
9. Regale 100% Pure, 1 gallon can
10. Regale Pomace, 1 gallon can. Recall #F-452/461-3.
CODE None.
MANUFACTURER Rubino U.S.A. Inc., Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter April 23, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximate amounts distributed are as follows:
(1) 18,276 cans; (2) 35,701 cans; (3) 132,787 cans;
(4) 398 drums; (5) 20,974 jugs; (6) 393 jugs;
(7) 320 jugs; (8) 2,000 cans; (9) 3,800 cans;
(10) 14,00 cans.
REASON Canola Oil has been substituted for Olive Oil in part
and/or a lower grade of Olive Oil was substituted for a
higher grade of Olive Oil.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
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PRODUCT Peritrate SA (Pentaerythritol Tetranitrate) Sustained
Action Tablets, in bottles of 100, indicated for the relief
of angina pectoris. Recall #D-278-3.
CODE All lots within expiration date.
MANUFACTURER Warner Lambert, Inc., Vega Baja, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris
Plain, New Jersey, by letter on or about June 1, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 253,550 units were distributed.
REASON Dissolution specification not assured through expiration
date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Mallinckrodt Medical Technescan DTPA Kit, for the
preparation of Technetium TC 99m Penetate, packaged in 5
vial kits and 30 vial kits. Recall #D-274-3.
CODE Lot #2272 EXP 8/95.
MANUFACTURER CIS-US, Inc., Bedford, Massachusetts.
RECALLED BY Manufacturer, by letters of May 11 and 14, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Panama, Mexico, Jamaica, Phillipines.
QUANTITY 402 5-packs and 254 30-packs were distributed.
REASON Expiration date is August 1994 instead of declared August
1995.
_______________
PRODUCT Equagesic Tablets (Meprobamate with Aspirin), in bottles of
100, used for the treatment of pain in patients with
musculoskeletal disease. Recall #D-275-3.
CODE Lot #9920691.
MANUFACTURER Wyeth-Ayerst Laboratories, St. Davids, Pennsylvania.
RECALLED BY Manufacturer, by letter May 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,978 bottles were distributed.
REASON Some tablets contain only the meprobamate component.
_______________
PRODUCT First Aid Spray, in 5 ounce spray container, under Pathmark
and Shoprite labels. Recall #D-276-3.
CODE Lot #2197 (produced by Bissell). Pathmark brand code:
JUL 1594 EXP 10/94; Shop Rite brand code: 2197 EXP 10/94.
MANUFACTURER Bissell, Inc., Barcolene Division, doing business as Penn
Champ, East Butler, Pennsylvania.
RECALLED BY Manufacturer, by telephone and by letters dated May 21 and
24, 1993. Firm-initiated recall ongoing.
DISTRIBUTION The east coast.
QUANTITY Undetermined.
REASON The pyrilamine maleate ingredient is subpotent.
_______________
PRODUCT Lidocaine HCl Oral Topical Solution, USP, 2% (viscous), an
Rx topical anesthesia for use on irritated mucous membranes
of the mouth and pharynx, in 20 ml (PBI label only) and 100
ml bottles under the following labels: PBI, GG (Geneva),
Goldline, Rugby, Qualitest, Major. Recall #D-277-3.
CODE Lot #19165 EXP 10/31/94 (100 ml) and 10/31/93 (20 ml).
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Pennex Pharmaceuticals, Inc., Morton Grove, Illinois, by
letter June 4, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,392 20-ml bottles and 86,979 100-ml bottles were
distributed.
REASON Superpotent.
_______________
PRODUCT CO-57 Schilling Test Kit, for oral administration, Rx used
for the diagnosis of addisonian (pernicious) anemia and as
a diagnostic adjunct in other defects of intestinal
absorption. Recall #D-279-3.
CODE Lot #4023002 EXP 9/4/93.
MANUFACTURER Mallinckrodt Medical, Inc., Maryland Heights, Missouri.
RECALLED BY Manufacturer, by telephone May 20-21, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION New York, Tennessee, California, Buenos Aires.
QUANTITY 52 kits were distributed.
REASON Vials containing the intrinsic factor capsules are labeled
with an expiration date of Sept 4, 1993 instead of July 21,
1993.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
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PRODUCT (a) Red Blood Cells; (b) Platelets, expired.
Recall #B-278/279-3.
CODE Unit #10196-6991.
MANUFACTURER United Blood Services Blood Systems, Inc., Scottsdale,
Arizona.
RECALLED BY Manufacturer, by letters dated March 31, 1992, and November
3, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, Massachusetts.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV), were distributed.
_______________
PRODUCT Platelets. Recall #B-281-3.
CODE Unit #Q60973.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone September 30, 1992. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product, which tested negative for syphilis, but was
collected from a donor who less than 12 months previous
tested confirmed positive syphilis, was distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Platelets Pooled, .
Recall #B-286/289-3.
CODE Unit numbers: (a) 60K35644; (b) 60E07079, 60E11344,
60G37719, 60H60478, 60H81322, 60J10071; (c) 60E11344,
60G37719; (d) 60N05249, 60M95271.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by letter September 9, 1991. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY (a) 1 unit; (b) 6 units; (c) 2 units; (d) 2 units.
REASON Blood products which were maintained at improper
temperatures during shipment; collected from an ineligible
donor who traveled to an endemic area for malaria; or
labeled with the incorrect expiration date were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-292-3.
CODE Unit numbers: T58753, T58754.
MANUFACTURER Topeka Blood Bank, Inc., Topeka, Kansas.
RECALLED BY Manufacturer, by telephone October 19, 1992. Firm-
initiated recall complete.
DISTRIBUTION Kansas.
QUANTITY 2 units.
REASON Blood products, which were glycerolized in preparation for
freezing but were not frozen within 18 hours, were
distributed for freezing and subsequent transfusion.
_______________
PRODUCT Recovered Plasma. Recall #B-293-3.
CODE Unit numbers: 6, 19 21, 22, 23, 234, 25, 26, 28.
MANUFACTURER Community Hospital of Lancaster, Lancasater, Pennsylvania.
RECALLED BY Manufacturer, by letter December 22, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 9 units.
REASON Blood products, untested for syphilis, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Plasma. Recall #B-294/295-3.
CODE Unit numbers: (a) 53T97031; (b) 53FL13851.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone January 21, 1993, followed by
letter March 22, 1993. Firm-initiated recall complete.
DISTRIBUTION Washington, D.C., Maryland.
QUANTITY 1 unit of each component.
REASON Blood products, corresponding to units of Platelets which
were implicated in a case of post-transfusion septicemia
with group B Streptococcus sp., were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
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PRODUCT Red Blood Cells. Recall #B-280-3.
CODE Unit #T62174.
MANUFACTURER Topeka Blood Bank, Inc., Topeka, Kansas.
RECALLED BY Consignee notified firm February 26, 1993. Firm-initiated
recall complete.
DISTRIBUTION Kansas.
QUANTITY 1 unit.
REASON Blood product which was labeled with an incorrect
expiration date was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-285-3.
CODE Unit numbers: 10190-2752, 10190-5783, 10190-5790,
10190-6904, 10190-7375, 10190-7378, 10190-8274.
MANUFACTURER United Blood Services Blood Systems, Inc., Scottsdale,
Arizona.
RECALLED BY Manufacturer, October 24, 1991. Firm-initiated recall
complete.
DISTRIBUTION Arizona.
QUANTITY 7 units.
REASON Blood products, which were incorrectly tested for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV), were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-290-3.
CODE Unit #60W71103.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by letter September 9, 1991, and by telephone
March 5, 1992. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product was labeled with the incorrect expiration
date and was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-291-3.
CODE Unit #12071-1817.
MANUFACTURER United Blood Services Blood Systems, Inc., Albuquerque, New
Mexico.
RECALLED BY United Blood Services Blood Systems, Inc., Scottsdale,
Arizona, by letter November 5, 1990. Firm-initiated recall
complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit.
REASON Blood product, corresponding to a unit of Red Blood Cells
which was implicated in a case of post transfusion Yersinia
Enterocolitica infection, was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-296-3.
CODE Unit numbers: 53H92012 and 53H92014.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by fax January 27, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 2 units.
REASON Blood products, corresponding to units of Platelets which
were implicated in a case of post-transfusion spepticemia
with group B Streptococcus sp., were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT 20.5 Diopter, Posterior Chamber Silicone Intraocular Lens
with UV Absorber, Model SI30NB. Recall #Z-549-3.
CODE Lots 47891 - 49012.
MANUFACTURER Allergan Medical Optics, Anasco, Puerto Rico.
RECALLED BY Allergan Medical Optics, Irvine, California, by telephone
March 23, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Georgia, Kansas, Massachusetts, New Jersey, Ohio,
Texas, Iowa, California, Connecticut, Louisiana, New York,
Washington state.
QUANTITY 32 units were distributed.
REASON Product was distributed without PMA approval for the Puerto
Rico manufacturing location.
MEDICAL DEVICE SAFETY ALERTS:
============================================
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PRODUCT Ventak Automatic Implantable Cardioverter-Defibrillators.
Safety Alert #N-013-3.
CODE All serial numbers of the 1500 and 1600 series.
MANUFACTURER Cardiac Pacemakers, Inc., St. Paul, Minnesota.
ALERTED BY Manufacturer, by letter November 30, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY 20,000 units were distributed.
REASON On November 30, 1992, the firm notified physicians and
users of the need to avoid static magnetic fields in the
vicinity of these devices since these fields are capable of
inactivating the device.
CRIMINAL INDICTMENT:
=====================================================
______________
AGAINST: Peninsular Products Company; Flavor Fresh Foods Corporation;
Edward B. Crouse; William B. Laviolette; George R. "Pete"
Reynolds; Saad Alhir; James R. Marshall; James E. Benton;
and Friedrich R. "Fred" Kohlbach; of Chicago, Illinois,
Lansing, Michigan, and the Republic of Germany. (United
States v. Flavor Fresh Foods Corp., et al.)
CHARGES In a 33-count Indictment the defendants were charged with
having conspired to violate the Federal Food, Drug, and
Cosmetic Act, having conspired to defraud the United States
by obstructing and impeding by trickery and deceit the Food
and Drug Administration of its functions of monitoring and
controlling the manufacture and sale of orange juice from
concentrate and concentrated orange juice for manufacturing,
with specific acts of adulteration and misbranding of food
products, and with violation of mail and wire fraud
statutes, in the use of the United States mails and wires to
perpetuate a scheme to defraud consumers of juice products.
In an Order for Dismissal dated March 30, 1993, the
Indictment was dismissed against the Defendant Peninsular
Products Co. because investigation by the United States has
determined that Peninsular has sold virtually all of its
assets including: trademarks, goodwill, customers, plant
and equipment.
FILED February 18, 1993 - Indictment; March 30, 1993 - Order for
Dismissal of Indictment against Defendant Peninsular
Products Co., Criminal #1:93:M:21; U.S. District Court for
the Western District of Michigan, Southern Division; FDC
#66106.
CRIMINAL INFORMATION:
====================================================
_______________
DEFENDANT Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
INFORMATION Duramed pled guilty to two misdemeanor counts of shipping an
unapproved new drug and one misdemeanor count of shipping an
adulterated drug in interstate commerce. The three counts
relate to abbreviated new drug applications filed with FDA
in mid-1986 for Prochlorperazine Maleate 10 mg Tablets and
Propranolol HCl/Hydrochlorothiazide 80/25 mg Tablets. As
part of the plea Duramed agreed to pay a $500,000 fine over
a three year period and signed a Consent Decree of Permanent
Injunction. Under the Consent Decree, the firm agreed not
to violate certain applicable laws, to continue to cooperate
with any further government investigation and to cooperate
with FDA during future inspections of the firm's facilities
or products.
FILED Information - May 11, 1993; Plea Agreement - May 24, 1993;
Criminal #HAR-93-0207, FDC #66101; May 24, 1993 - Consent
Decree of Permanent Injunction, Civil #HAR93-1515, INJ 1328;
U.S. District Court for the District of Maryland.
SEIZURE:
=================================================================
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Product Prostazinc tablets (93-556-601).
CHARGES New drug - The article is an unapproved new drug.
Misbranded - The article's labeling is false and misleading,
fails to contain all required words, statements, and other
information, and fails to bear adequate directions for use.
FIRM Food Health Services & Ideas, Miami, Florida.
FILED March 23, 1993; U.S. District Court for the Southern
District of Florida; Civ. #93-0521-CIV-ATKINS; FDC #66656.
SEIZED March 24, 1993 - goods valued at approximately $50,000.
END OF ENFORCEMENT REPORT FOR JUNE 16, 1993. BLANK PAGES MAY FOLLOW.
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