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
06/23/1993
Recalls and Field Corrections: Foods -- Class II -- 06/23/1993
June 23, 1993 93-25
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
_______________
PRODUCT Dutch Chocolate Cake, gluten and lactose free, 12 ounces.
Recall #F-447-3.
CODE Lot numbers KM1A and BQ2A.
MANUFACTURER Red Mill Farms, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter May 5, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Undetermined.
QUANTITY Approximately 270 cases (12 units per case) were distributed.
REASON Product is contaminated with undeclared walnuts.
_______________
PRODUCT Meijer brand Apple Sauce, Natural, No sugar Added, in 50
ounce glass jars. Recall #F-481-3.
CODE Lot numbers: 0832LR and 11093/MBK17H.
MANUFACTURER Comstock Michigan Fruit Division, Rochester, New York (lot
0832LR); Knouse Foods, Inc., Paw Paw, Michigan.
RECALLED BY Meijer, Inc., Grand Rapids, Michigan, by telephone October 2,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Michigan, Ohio.
QUANTITY 30,096 jars were distributed.
REASON The labels for the unsweetened applesauce were placed on the
sweetened applesauce.
_______________
PRODUCT Trail Mix products: (a) California Aloha Trail Mix;
(b) R & E Deluxe Trail Mix, each packed and distributed by
Royal Candy Co., Inc., in clear cellophane bags, 1/2 ounces.
Recall #F-482/483-2.
CODE None.
MANUFACTURER Royal Candy Company, Inc., Brooklyn, New York (repacker).
RECALLED BY Repacker, by telephone on or about May 12, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York, Georgia, Illinois, Virginia, Maryland.
QUANTITY Approximately 15 dozen bags of each product were distributed.
REASON Product contains undeclared sulfites.
_______________
PRODUCT Smoked Salmon: (a) Lemon Pepper Smoked Salmon, in , in
plastic vacuum packed bag with a stick on label; (b) Cajun
Style Smoked Salmon, in plastic vacuum packed bag with a
stick on label. Recall #F-484/485-3.
CODE All codes that do not contain the proper color declaration.
MANUFACTURER Sea Sausage, Inc., Sea-Tac, Washington.
RECALLED BY Manufacturer, by visit after May 20, 1993. Firm-initiated
field correction (relabeling) ongoing.
DISTRIBUTION Washington state.
QUANTITY Approximately 500-800 pounds are distributed weekly.
REASON Product contains undeclared FD&C Yellow No. 5 & 6, and Red
No. 40.
_______________
PRODUCT Hostess brand Walnut Brownie Bites, in multi-package 8 ounce
cartons. Recall #F-486-3.
CODE Lot #533214. Carton marked with a pick-up date of 9/5/92 and
EXP 9/9/92.
MANUFACTURER Continental Baking Company, Inc., Indianapolis, Indiana.
RECALLED BY Continental Baking Company, Inc., St. Louis, Missouri, by
letter September 4, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,239 cartons were recalled.
REASON Product does not declare walnuts on the carton label.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=======================
_______________
PRODUCT Instant tea: (a) Tea with Lemon Drink, in bulk 50 pound bags
of instant tea; (b) Keefe Instant Tea with Lemon and Sugar,
in 12 ounce envelopes. Recall #F-462-463-3.
CODE Lot numbers: (a) 111217922020 through 111217922029;
(b) FEB 11 1993 and FEB 12 1993.
MANUFACTURER Consolidated Flavors Corporation, Bridgeton, Missouri.
RECALLED BY Manufacturer, by telephone approximately February 17, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 602 bags; (b) 1,282 cases (18 envelopes per case) were
distributed.
REASON Product is contaminated with pieces of shredded teflon
sealer.
_______________
PRODUCT Health for Life brand L-Carnitine, 250 mg Caplets, in bottles
of 30, nutritional supplement. Recall #F-487-3.
CODE 05739 3/95.
MANUFACTURER Gemini Pharmaceuticals, Inc., Bohemia, New York.
RECALLED BY Triage Pharmaceutical, Inc., Syracuse, New York, by
Administrative Bulletin 93-02, dated May 13, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Virginia, Maryland, Georgia, North
Carolina, Texas, Ohio, Florida, Minnesota, Wisconsin,
Arizona, Kentucky, Indiana, California, Washington state,
Oregon.
QUANTITY 1,056 bottles were distributed.
REASON Product is subpotent.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
_______________
PRODUCT Neomycin Sulfate Tablets, 500 mg, in bottles of 100, a Rx
antibiotic, Recall #D-282-3.
CODE All lots.
MANUFACTURER Eon Labs Manufacturing, Inc., Laurelton, New York.
RECALLED BY Manufacturer, by telephone by letter June 11, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 21,000 bottles were distributed.
REASON Discrepancies in manufacturing procedures.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT (a) Donnazyme Tablets, in 100 tablet bottles, Pancreatin, USP
equivalent 500 mg; (b) Entozyme Tablets, in 100 tablet
bottles, Pancreatin, USP equivalent 300 mg.
Recall #D-280/281-3.
CODE All lots.
MANUFACTURER Whitehall-Robins, Richmond, Virginia.
RECALLED BY Manufacturer, by letter May 25, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY Undetermined.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
_______________
PRODUCT Red Blood Cells. Recall #B-277-3.
CODE Unit #6045192.
MANUFACTURER Community Blood Center, Inc., Appleton, Wisconsin.
RECALLED BY Manufacturer, by letter January 12, 1993. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit.
REASON Red Blood Cells, prepared from a Whole Blood unit stored at
room temperature more than eight hours after collection, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated AHF.
Recall #B-282/284-3.
CODE Unit numbers: (a) 10193-5281, 10193-6148, 10195-3814, 10195-
8635, 10196-3751, 10196-8214, 10196-9243, 10197-2858, 10197-
4035, 10197-4601, 10198-6137;
(b) 10193-5281, 10193-6148, 10195-8635;
(c) 10196-9243, 10197-4601, 10198-6137.
MANUFACTURER United Blood Services Blood Systems, Inc., Scottsdale,
Arizona.
RECALLED BY Manufacturer, by letter June 4, 1992. Firm-initiated recall
complete.
DISTRIBUTION Arizona.
QUANTITY (a) 11 units; (b) 3 units; (c) 3 units.
REASON Blood products which tested reactive for syphilis were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-297-3.
CODE Unit #CU6645.
MANUFACTURER Sera-Tec Biologicals, Salt Lake City, Utah.
RECALLED BY Consignee notified firm by telephone September 21, 1992, and
Manufacturer sent facsimile on September 22, 1992. Firm-
initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product untested for viral markers was distributed for
further manufacture into injectable products.
_______________
PRODUCT Platelets. Recall #B-298-3.
CODE Unit numbers: 19GJ03779, 19GJ03781, 19GJ03798, 19GJ03791,
19GJ03808, 19GJ03810.
MANUFACTURER American Red Cross, Blood Services, Paducah, Kentucky.
RECALLED BY Manufacturer, by telephone March 2, 1992, and by letter March
9, 1992. Firm-initiated recall complete.
DISTRIBUTION Kentucky.
REASON Blood products labeled with the incorrect expiration dates
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Plasma. Recall #B-299/300-3.
CODE Unit numbers: (a) 53FJ07015, 53FJ07016, 53G70895, 53L44087,
53T94586, 53X70635, 53X70636; (b) 53X70635, 53X70635,
53X70636.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland
RECALLED BY Manufacturer, by letter December 18, 1992. Firm-initiated
recall complete.
DISTRIBUTION Washington, D.C., Maryland.
QUANTITY (a) 7 units; (b) 3 units.
REASON Blood products, corresponding to units of Platelets which
were pooled and possibly contaminated with Staphylococcus
epidermidis, were distributed.
_______________
PRODUCT Immu-Sal Immunohematological Saline. Recall #B-302-3.
CODE Lot numbers: 2100, 2105, 2120, 2131, 2142, 2169, 2173.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter in July 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Spain.
QUANTITY 601 units were distributed.
REASON Diagnostic reagents, which demonstrated unexpected negative
or weakly reactive reactions, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Recovered Plasma. Recall #B-301-3.
CODE Unit numbers: 53FJ07015, 53FJ07016, 53G70895, 53L44087.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland
RECALLED BY Manufacturer, by letter December 18, 1992. Firm-initiated
recall complete.
DISTRIBUTION Washington, D.C., Maryland, California.
QUANTITY 4 units.
REASON Blood products, corresponding to units of Pooled Platelets
which were possibly contaminated with Staphylococcus
epidermidis, were distributed for further manufacture into
injectable products.
CRIMINAL INFORMATIONS: ==============================================
_______________
AGAINST Mark Saur, owner and officer, and Apple Valley
International, Inc., a corporation, Sparta, Michigan.
CHARGES Mr. Saur pled guilty to a three-count misdemeanor
Information for interstate shipment of adulterated food
that had been labeled and represented as unsweetened orange
juice concentrate, but was adulterated by substituting
invert beet sugar for part of the orange juice concentrate.
Apple Valley International also pled guilty, but to a
three-count felony Information. The felony counts were
charged because interstate shipments were made with the
intent to defraud and mislead. Mr. Saur was sentenced to a
fine of $99,999, plus a special assessment of $25 per
count. Apple Valley was fined a total of $480,000, plus a
special assessment of $600 per count. The fines must be
paid within 90 days and the assessments must be paid
immediately.
FILED April 1, 1993 - Information; May 28, 1993 - Sentencing;
U.S. District Court for the Western District of Michigan,
Southern Division; Criminal Nos. 1:93-M-373 and 1:93:CR:49;
FDC #65991.
INJUNCTION ACTIONS:
======================================================
_______________
PRODUCT Thyroid Tablets, et al (92-633-613).
AGAINST Richlyn Laboratories, Inc., a corporation and Richard S.
Weinberg, an individual, Philadelphia, Pennsylvania.
CHARGE The defendants are permanently enjoined from the interstate
shipment of any drug that is misbranded because its labeling
is false or misleading. They are further enjoined from the
interstate shipment of drugs that are adulterated because
the methods used in, or the facilities or controls used for,
their manufacture, processing, packing, or labeling are not
in conformity with current good manufacturing practice
regulations. Further, the defendants must comply with the
specific terms and obligations in the order of permanent
injunction.
FILED September 21, 1992 - Restraining Order; October 1, 1992 -
Order for Preliminary Injunction signed; May 25, 1993 -
Order for Permanent Injunction; U.S. District Court for the
Eastern District of Pennsylvania; Civil #92-CV-5464;
INJ #1296.
_______________
PRODUCT Drug products (91-613-667).
AGAINST Able Laboratories, Inc., a corporation; and Murty Vepuri
and Paul Manning, individuals, South Plainfield, New
Jersey.
CHARGE Adulterated - The methods used in, or the facilities or
controls used for, the manufacture, processing, packing, or
holding do not conform to or are not operated or
administered in conformity with current good manufacturing
practice regulations.
FILED November 6, 1991 - U.S. District Court for the District of
New Jersey; March 2, 1992 - Agreed Order of Permanent
Injunction, signed by both parties and the District Court
Judge.
CONTEMPT May 25, 1993 - U.S. District Court for the District of New
ACTION Jersey, Civil #91-4916 (AJL); INJ #1268 and 1268A;
Stipulated Order, amending the Agreed Order of Permanent
Injunction.
DISPOSITION The Stipulated Order limits the individual defendants'
activities at the firm, sets financial penalties for
violations of the agreed order, and names the manner in
which the firm will be notified if a partial or complete
shutdown is required. As a separate part of the overall
settlement, A.L. Laboratories, the owner of Able
Laboratories, paid to the U.S. Treasury a total of
$45,611--The costs for prosecuting the contempt action.
MASS SEIZURE ACTIONS:
====================================================
_______________
PRODUCT Disopyramide Phosphate 100 mg. Extended Release Capsules
and other quantities of in-process and finished solid
dosage form drugs (tablets and capsules only) (93-605-588
et al.).
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
or administered in conformity with current good
manufacturing practice requirements.
FIRMS KV Pharmaceutical Company, at seven different locations,
St. Louis, Missouri; and, at Highland Packaging Company,
St. Louis, Missouri.
FILED April 20, 1993; U.S. District Court for the Eastern
District of Missouri, Eastern Division; Civil ##4:93CV00919
and 4:93CV00918; FDC ##66706 and 66709.
SEIZED April 21 , 1993 - goods valued at $28 million and
$3 million.
SEIZURE ACTION:
==========================================================
_______________
PRODUCT Cathy's EXTRA STRENGTH Guarana Capsules and Cathy's Herbal
Cellulite Treatment and accompanying labeling
(93-700-038, et al.).
CHARGES New drug - No approved applications are in effect for such
drugs. Misbranded - The articles' labels fail to bear
adequate directions for use.
FIRM Bill's Wholesale, Inc., and Bill's Health Foods, Inc.,
Albany, Georgia.
FILED May 13, 1993; U.S. District Court for the Middle District
of Georgia; Civil #93-56-ALB-AMER; FDC #66699.
SEIZED May 28, 1993 - goods valued at approximately $65,000.
-7-
END OF ENFORCEMENT REPORT FOR JUNE 23, 1993. BLANK PAGES MAY FOLLOW.
####