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
12/21/1994
Recalls and Field Corrections: Foods -- Class II -- 12/21/1994
December 21, 1994 94-51
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Coca Cola Classic, in 2 liter plastic bottles.
Recall #F-135-5.
CODE Code beginning with APR0395TWE.
MANUFACTURER Coca-Cola Bottling Company of Buffalo, Inc., Buffalo, New
York.
RECALLED BY Manufacturer, by visit from approximately November 7-10, 1994,
followed by letter November 11, 1994. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 3,616 cases (8 bottles per case) were distributed.
REASON Product contains gear lubricant.
_______________
PRODUCT Light n' Lively Free 50 Calories, Non-Fat Yogurt with
Aspartame Sweetener, variety pack, 3 Strawberry Fruit Cup &
3 Strawberry Banana, in 4.4 ounce plastic cups.
Recall #F-136-5.
CODE NOV 18.
MANUFACTURER Kraft, Inc. Dairy Group, Atlanta, Georgia.
RECALLED BY Kraft General Foods, Inc., Northfield, Illinois, by fax
November 2, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Indiana, Wisconsin, North Carolina, Florida,
Alabama, Arkansas, Tennessee, Georgia, Missouri, Minnesota,
Michigan, Virginia, West Virginia.
QUANTITY 3,153 cases were distributed; firm estimated that 20% of the
yogurt remained on market at time of recall initiation.
REASON Product contains metal shavings.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Promise Extra Light Margarine, packaged in 16 ounce boxes,
four 1/4 pound sticks per box. Recall #F-133-5.
CODE NOV 2194K.
MANUFACTURER Van Den Bergh Foods, New York, New York.
RECALLED BY Manufacturer, by letter August 8, 1994. Firm-initiated recall
complete.
DISTRIBUTION Washington state, California, Utah, Hawaii.
QUANTITY 371 cases (18 packages per case) were distributed.
REASON Product is contaminated with mold.
_______________
PRODUCT Jumex Apple Juice Drink in 8.4 fluid ounce plastic bottles.
Recall #F-134-5.
CODE All lots.
MANUFACTURER Empacadora de Frutas y Jugos, S.A. de C.V., Mexico City,
Mexico.
RECALLED BY Vilore Foods Company, Inc., Laredo, Texas, by letter September
15, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Texas.
QUANTITY 1,680 cases (24 bottles per case) were distributed; firm
estimated that 200 cases remained on market at time of recall
initiation.
REASON Product is contaminated with yeast growth.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Prednisone Tablets, USP, 10 mg, Rx oral glucocorticoid anti-
inflammatory used in the treatment of rheumatoid arthritis and
adrenocortical insufficiency, packaged in bottles of 15, 40,
and 20 tablets. Recall #D-039-5.
CODE Lot numbers: 4049042, 4122011, 4049047.
MANUFACTURER Purepac Pharmaceutical Company, Elizabeth, New Jersey
(responsible firm).
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letter September 8, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Michigan, Connecticut, California, Missouri, Florida, Nevada,
North Carolina, Georgia.
QUANTITY 33 bottles of 15 tablets and 49 bottles of 40, and 2 bottles
of 20 tablets were distributed; firm estimated that 25 percent
of product remained on market at time of recall initiation.
-2- REASON Product may not meet dissolution specifications through
expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Bactroban brand of Mupirocin Ointment, 2%, a topical
antibacterial, packaged in 1 gram single unit packages of 50,
1 gram patient starter samples boxes of 20, 15, and in 30 gram
tubes. Recall #D-036-5.
CODE All lots.
MANUFACTURER SmithKline Beecham Pharmaceuticals, Cidra, Puerto Rico.
RECALLED BYSmithKline Beecham Pharmaceuticals, Bristol, Tennessee, by Fax
November 18, 1994, and by letter dated November 21, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Failure to meet potency and/or total degradation
specifications through expiration date.
________________
PRODUCT Acetaminophen Tablets, Regular Strength, packaged in bulk
drums. Recall #D-037-5.
CODE Lot #4083119.
MANUFACTURER Granutec, Inc., Wilson, North Carolina.
RECALLED BY Manufacturer, by issuing a return authorization on October 16,
1994. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 7.9 million tablets.
REASON Presence of metallic particles.
_______________
PRODUCT Bulk Naltrexone Hydrochloride Powder, used for further
manufacture of a drug prescribed for substance abuse problems.
Recall #D-038-5.
CODE 1479SMH060, 1479SMH061, 1479SMJ064, 1479SMJ066, 1479SMK067.
MANUFACTURER Mallinckrodt Chemical, Inc., St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone October 12, 1994, and by letter
October 18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Colorado, New York, Portugal.
QUANTITY 36.1 kg were distributed between 6/14/94 and 8/8/94.
REASON Product exceeds specification for total water and ethanol
content.
_______________
PRODUCT Cherry Nytime, a liquid OTC cough and cold drug product, in 6
fluid ounce bottles. Recall #D-040-5.
CODE Lot #J256.
MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New York.
-3- RECALLED BY Manufacturer, by telephone March 29, 1994. Firm-initiated
recall complete.
DISTRIBUTION Minnesota.
QUANTITY 10,666 units were distributed; firm estimates none remains on
the market.
REASON Alcohol component did not meet USP specifications for Non-
volatile Impurities.
_______________
PRODUCT Oxycodone and Acetaminophen Tablet, 5 mg/325 mg, prescription
oral analgesic, in 100 and 500 tablet bottles, under the
following labels: Halsey; Schein, Qualitest, Goldline.
Recall #D-041-5.
CODE Lot numbers: 3J30F, 3J30L, 3L10F.
MANUFACTURER Halsey Drug Company, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter December 19, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15,448 100-tablet bottles and 2,581 500-tablet bottles were
distributed.
REASON Oxycodone ingredient does not meet potency specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS --
=============================
_______________
UPDATE Regarding Recall #B-024/026-5 which appeared in the November
16, 1994 Enforcement Report: The report stated the reason as
blood components contaminated with "Coagulase negative
Streptococcus agalactiae Group B were distributed;" however,
it should have been reported as blood products contaminated
with "Streptococcus agalactiae Group B" were distributed.
These recalls were classified as follows:
B-024-5 - Class I; B-025-5 - Class II; B-026-5 - Class III.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-106/107-5.
CODE Unit #27028-4638.
MANUFACTURER United Blood Services Blood Systems, Inc., Texarkana, Texas.
RECALLED BY Manufacturer, by telephone September 28, 1993, followed by
letter September 30, 1993. Firm-initiated recall complete.
DISTRIBUTION Arkansas, Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had a
history of intravenous (IV) drug use, were distributed.
-4- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Whole Blood CPDA-1. Recall #B-105-5.
CODE Unit #FS13010.
MANUFACTURER Delta Blood Bank, Stockton, California.
RECALLED BY Manufacturer, by telephone October 10, 1990. This firm
initiated recall was completed in 1990.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect expiration
date, was distributed.
_______________
PRODUCT Platelets Pheresis. Recall #B-104-5.
CODE Unit #9202863.
MANUFACTURER Hunter Blood Center, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter September 4, 1993. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who had
received the Rubella vaccine two weeks prior to donation, was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Easy Cap Disposable End-Tidal Carbon Dioxide Detector, used to
assist in verification of endotracheal tube placement after
intubation and during patient transport.
Recall #Z-105-5.
CODE All lots with lot designator "J".
MANUFACTURER Harmac Medical Products, Inc., Buffalo, New York.
RECALLED BY Nellcor, Inc., Pleasanton, California, by letters sent August
18, 1993 and in October 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 306,456 units were distributed; firm estimates none remains on
the market.
REASON The device was found to contain an extra plastic cap within
the lower chamber of the detector, resulting in a possible
airflow obstruction.
_______________
PRODUCT OPX Fiberoptic Intracranial Pressure Monitoring Catheter Kits:
(a) Model OPX-SD; (b) Model OPX-V. Recall #Z-176/177-5.
CODE All lots.
MANUFACTURER Innerspace, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter August 29, 1994. Firm-initiated
recall ongoing.
-5- DISTRIBUTION Arizona, California, Florida, Illinois, Kansas, Missouri,
North Carolina, Nebraska, New Jersey, New York, Oklahoma,
Pennsylvania, Tennessee, Texas, Wisconsin, Washington, D.C.,
Brazil, Canada, France, Germany, Israel, Netherlands,
Switzerland, United Kingdom.
QUANTITY 590 units were distributed. On October 12, 1994, the firm
estimated that 156 units remained in commerce.
REASON The leakage caused by a defective seam may cause inaccurate
pressure readings.
_______________
PRODUCT Tandem R CEA Immunoradiometric Assay Kits, Catalog #3063, in-
vitro device indicated for the quantitative measurement of
carcinoembryonic antigen (CEA) in human serum to be used as an
aid in the prognosis and management of cancer patients.
Recall #Z-201-5.
CODE Lot numbers: 491001 EXP 9/7/94, 491062 EXP 9/21/94, 491092
EXP 9/28/94, 491109 EXP 10/5/94, 491154 EXP 10/12/94, 491216
EXP 10/26/94, 491249 EXP 10/26/94.
MANUFACTURER Hybritech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter October 14, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada, Chili.
QUANTITY 582 kits were distributed from 7/25/94 through 9/14/94.
REASON Insufficient mouse IgG was added to diluent during manufacture
which results in the false elevation of patient test results.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Cadwell Spectrum 32 Neurometric Analyzer, an EEG device, and
the Neurometric EEG Software. Recall #Z-175-5.
CODE All units which have the Neurometric software program.
MANUFACTURER Cadwell Laboratories, Inc., Kennewick, Washington.
RECALLED BY Manufacturer. A software update package was sent to all
consignees in February 1994. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 218 packages were distributed.
REASON The discriminant analysis within the Neurometric software
provided false positive and false negative readings, which
could result in misdiagnosis.
_______________
PRODUCT SurgiQuip Power Console, Catalog #100-001, used to power
SurgiQuip hand-held orthopedic surgical instruments.
Recall #Z-178-5.
-6- CODE Serial numbers: 01002, 01003, 01005, 01006, 01007, 01008,
01010, 01011, 01013, 01014, 01015, 01017, 01018, 01019, 01021,
01022, 01023, 01026, 01027, 01028, 01029, 01030, 01031, 01032,
01033, 01034, 01036, 01037, 01038, 01039, 01040, 01041, 01043,
01045, 01046, 01047, 01048, 01050, 01051, 01052, 01053, 01054,
01057, 01058, 01059, 01060, 01061, 01062, 01063, 01064, 01065,
01066, 01067, 01068, 01069, 01070, 01072, 01075, 01076, 01077,
01079, 01080, 01081, 01082, 01083, 01086, 01088, 01089, 01091,
01092, 01093, 01094, 01095, 01096, 01098, 01100, 01103, 01104,
01106, 01107, 01108, 01109, 01110, 01111, 01113, 01114, 01115,
01116, 01119, 01120, 01121, 01123, 01124, 01125, 01126, 01127,
01129, 01130, 01131, 01132, 01134, 01135, 01136, 01138, 01139,
01140, 01141, 01143, 01144, 01146, 01147, 01148, 01149, 01150,
01151, 01152, 01153, 01154, 01155, 01156, 01157, 01158, 01159,
01160, 01161, 01163, 01164, 01165, 01167, 01168, 01169, 01171,
01172, 01173, 01176, 01177, 01178, 01179, 01180, 01182, 01183,
01184, 01187, 01189, 01190, 01191, 01192, 01195, 01205, 01206,
01209, 01210, 01211, 01212, 01214, 01215, 01216, 01217, 01218,
01219, 01220, 01229, 01231, 01238, 01241, 01254, 01270, 01275,
01281, 01285, 01293, 01304, 01305, 01309, 01313, 01314, 01316,
01318, 01320, 01400, 01682, 01706, 01708, 01727, 01742, 01732,
01751, 01754, 01767, 01779, 01792.
MANUFACTURER SurgiQuip, Inc., Tulsa, Oklahoma
RECALLED BY Manufacturer, by letter September 20, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 191 units were distributed between July 1 and September 20,
1994.
REASON The console may be subject to temporary power shut-down due to
electrical interference generated from other operating room
equipment.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Diagnostic Ultrasound Systems: (a) SPA 1000; (b) DRF 800.
Safety Alert #N-003/004-5.
CODE All codes and serial numbers.
MANUFACTURER Diasonics Ultrasound, Inc., Milpitas, California.
ALERTED BY Manufacturer, by letter September 20, 1994.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON There is a potential for receiving a mild electric shock when
cleaning the logo on the machines with an electrolyte
solution.
-7-
END OF ENFORCEMENT REPORT FOR DECEMBER 21, 1994. BLANK PAGES MAY
FOLLOW.
####