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
03/20/1990
FDA Enforcement for the week of March 21, 1990
FDA ENFORCEMENT REPORT
FOR MARCH 21, 1990
March 21, 1990
Recalls and Field Corrections:
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.
NONE
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: Quality Freshly Shucked Raw Oysters, in 1 gallon plastic
pails. Recall #F-454-0.
Code: 1/9/90 handwritten on lids.
Manufacturer: Nick's Seafood No. 2, Eastpoint, Florida (packer/schucker).
-1-
Recalled by: Manufacturer, by telephone January 5, 1990. Firm-initiated
recall complete.
Distribution: Florida, Georgia.
Quantity: 66 gallons were distributed; firm estimates none remains
on market.
Reason: Salmonella contamination.
----
Product: Morning Sun brand Canned Mushrooms, pieces and stems,
in #10 cans. Recall #F-455-0.
Code: Q15 embossed on the top line of a three line can code.
Manufacturer: Fuzhou Cannery, Fujian, People's Republic of China.
Recalled by: Woo Chee Chong, Inc., San Diego, California, by
telephone between December 28, 1989 and January 5, 1990.
Firm-initiated recall complete.
Distribution: California, Mexico.
Quantity: 863 cases (6 cans/case) were distributed; firm estimates
none remains on market.
Reason: Contamination with staphylococcal enterotoxin.
----
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: New England Clam Chowder, Ready to Serve, Campbell's
Chunky Soup, in 19 ounce cans. Recall #F-451-0.
Code: SEP 91 ****/CTB8DPT.
Manufacturer: Campbell Soup of Texas, Paris, Texas.
Recalled by: Manufacturer, by letter December 27, 1989. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: 43,740 cans were distributed; firm estimates none remains
on market.
Reason: Product was contained in leaking cans.
----
Product: (a) Brown'n Serve Rolls, 12 per package, under the
following labels: Always Save, Big John, County Market,
Dixie Maid, E.W. James & Sons, Flav-O-Rite, Food 4 Less,
Foodland, Fresh Bake, Golden Bake, Hays, Hyde Park,
Janet Lee, Mayflower, Mega, Piggly Wiggly, Sack and Save
Foods, Sally's, Shur Fresh, Skaggs Alpha Beta, Smitty's,
Super Valu, Top Fresh, Wayne Lee's;
(b) Brown'n Serve Mini French Rolls, 16 per package,
under the Top Fresh and Colonial labels.
Recall #F-452/453-0.
Code: All lots manufactured prior to January 31, 1990.
Manufacturer: Hardin's Bakery, Meridian, Mississippi.
-2-
Recalled by: Campbell Taggart, Inc., Dallas, Texas, by salesman visit
January 30, 1990. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: Firm estimates none remains on market.
Reason: Objectionable odor from soybean oil ingredient.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
Product: Goldline brand Carisoprodol Tablets, 350 mg., in 100
tablet bottles, an Rx oral centrally acting skeletal
muscle relaxant. Recall #D-171-0.
Code: Lot numbers: 824039, 844059, 863069, 882079, 883079, 919099.
Manufacturer: Bolar Pharmaceuticals Company, Inc., Copiague, New York.
Recalled by: Manufacturer, by letter February 13, 1990. Firm-initiated
recall ongoing. (See Press Release - P90-13 issued
February 13, 1990)
Distribution: Goldline Laboratiries distribution centers located in
Connecticut, Texas, Florida, California, Ohio.
Quantity: Approximately 43,920 bottles were distributed.
Reason: A bottle of Goldline brand carisoprodol 350 mg tablets
was found mislabeled as Goldline brand doxycycline hyclate
100 mg tablets.
----
Class II -
Product: Timentin brand of Sterile Ticarcillin Disodium Clavulanate
Potassium Powder for Reconstitution, 3.1 grams, add-vantage
antibiotic vial for interavenous administration. Recall
#D-164-0.
Code: Lot #MM4117 EXP 1/91.
Manufacturer: Beecham Laboratories, Piscataway, New Jersey.
Recalled by: Beecham Laboratories, Bristol, Tennessee, by letter
February 12, 1990. Firm-initiated recall ongoing.
Distribution: Illinois, Indiana, Kansas, Michigan, Minnesota,
Mississippi, Missouri, Ohio, South Dakota, Wisconsin.
Quantity: 16,970 vials were distributed; firm estimates very few,
if any of this lot remains on market.
Reason: Lack of assurance of sterility.
----
Class III -
Product: Major brand Pseudo-gest Plus Tablets, in 100 tablet bottles,
an OTC immediate release nasal decongestant/antihistamine.
Recall #D-165-0.
-3-
Code: Lot numbers: G996701 EXP 7/91, H900001 EXP 9/91.
Manufacturer: Private Formulations, Inc., Edison, New Jersey.
Recalled by: Manufacturer, by letters November 1, and 22, 1989.
Firm-initiated recall ongoing.
Distribution: California, Michigan, Washington state.
Quantity: 6,072 bottles were distributed, firm estimates 1,797 remain
at the retail level.
Reason: Labeling error. Directions for use were omitted from
product label.
----
Product: Bacitracin Ointment USP, 500 units per gram in 1 ounce
tubes an OTC antibiotic for topical application.
Recall #D-166-0.
Code: All lots.
Manufacturer: Eli Lilly and Company, Indianapolis, Indiana.
Recalled by: Manufacturer, by letters February 13 and 16, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm-estimates 6,000 tubes remain on market.
Reason: Stability testing reveals product potency not assured
through expiration date.
-----
Product: Rugby brand Guiaphed Elixir, 16 ounce bottle, an OTC oral
liquid preparation used as a bronchodilator-decongestant.
Recall #D-167-0.
Code: Lot numbers: 92735, 92252.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter February 13, 1990. Firm-initiated
recall ongoing.
Distribution: New York.
Quantity: 1,368 bottles were distributed.
Reason: Labeling error - Product contains 19 percent alcohol.
Alcohol content not declared on label.
----
Correction: Reagent Red Blood Cells, Search-Cyte TCS III,
Recall #B-079-0, which appeared in the February 7, 1990
Enforcement Report should read:
Reason: Lutheran (Lua) positive Reagent Red Blood Cells
labeled Lua negative were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
-4-
Class II -
Product: Model TM-14-15RH Television Monitor. Recall #Z-438-0.
Code: Various
Manufacturer: Ikegami Tsushinki Co., Ltd., Tokoyo, Japan.
Recalled by: Ikegami Electronics (USA), Inc., Maywood, New Jersey,
Corrective action plan approved February 16, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 104 units were distributed.
Reason: Noncompliance with performance standards for electronic
products in that the controls for the power boards in the
units were not properly sealed.
----
Product: VISTA Nurse Station, Model 210, Versions 1040, 1060, 1080,
a video monitor using microprocessor technology to provide
monitoring capabilities of a hospital patient's vital
signs. Recall #Z-440-0.
Code: All serial numbers.
Manufacturer: Mennen Medical, Inc., Clarence, New York.
Recalled by: Manufacturer, by letter February 6, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,625 units were distributed.
Reason: If an ECG alarm condition occurs and the alarm has been
silenced, and the patient has not yet returned to within
programmed alarm limits, a second (different) ECG alarm
from that patient would not be indicated with an audible
alarm tone or documented on a hard-copy strip.
----
Product: InterVascular brand Poly-graft Elastomer Coated Dacron
Vascular Prothesis, Sterile, indicated for the
replacement or bypass procedures in aneurysmal and occlusive
disease of the thoracic and abdominal aorta, visceral
arteries and proximal peripheral arteries exclusive of the
coronary arteries:
(a) Poly-Graft-W;
(b) Poly-Graft-K;
(c) Poly-Graft-RS. Recall #Z-443/445-0.
Code: All codes.
Manufacturer: Intervascular, Inc., Clearwater, Florida.
Recalled by: Manufacturer, by letter January 22, 1990. Firm-initiated
recall ongoing.
Distribution: Alabama, Florida, Georgia, Louisiana, New Jersey, North
Carolina, Massachusetts, Pennsylvania, Tennessee, Ohio,
Mississippi, Rhode Island, California, Puerto Rico.
Quantity: 570 units were distributed.
-5-
Reason: Appropriate premarketing procedures for a 510(k) or PMA
approval were not followed by the firm prior to distribution
of this device.
----
Class III -
Product: Cat-A-Kit Assay System, an in-vitro diagnostic kit for the
radioenzymatic assay of adrenaline, noradrenaline and
dopamine (catecholamines) in urine, plasma or other
biological specimens. Recall #Z-439-0.
Code: Lot numbers: 18A EXP 3/2/90, 19A EXP 5/10/90.
Manufacturer: Amersham International plc, Cardiff Laboratories, Cardiff,
UK.
Recalled by: Amersham Corporation, Arlington Heights, Illinois, by
telephone December 18, 1989 for lot #18A and by
telephone January 31, 1990 for lot 19A. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 100 kits of lot 18A and 146 kits of 19A were distributed;
firm estimates 45 kits of lot 18A and 128 kits of lot 19A
remain on market.
Reason: Plasma controls are out of specifications. Plasma controls
in lot 18A gave sporadic low results, with vial to vial
variability. The COMT enzyme component of lot
19A has a pH lower than that allowed by specification (4.4
instead of 7.0 to 8.4).
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
NONE
Class III -
Product: Moorman's BMD * 30 (Bacitracin Methylene Disalicylate)
Type A Medicated Article, in 50 pound bags, for use in
medicating swine, broiler chickens, growing turkeys,
pheasants, quail and feedlot beef cattle rations.
Recall #V-036-0.
Code: Product #896, lot #3013 EXP 12/91.
Manufacturer: A.L. Laboratories, Inc., Chicago Heights, Illinois.
Recalled by: A.L. Laboratories, Inc., Fort Lee, New Jersey, by
letter February 13, 1990. Firm-initiated recall ongoing.
Distribution: The Midwest.
Quantity: 880 bags were distributed; firm estimates 25 percent
remains on market.
-6-
Reason: Some bags were mislabeled as Moorman's BMD * 50 Type A
Medicated Article, product #878, instead of Moorman's
BMD * 30 Type A Medicated Article product #896. Due to
this mislabeling the product becomes subpotent.
----
Seizure Actions Filed:
Product: All foods in rodent susceptible containers (90-575-347).
Charge: Product was held under insanitary conditions.
Firm: Dierks, Inc., Rockford, Illinois.
Filed: February 28, 1990 - U.S. District Court for the Northern
District of Illinois, Western Division; Civil #90-C-20064,
FDC #65833.
----
Product: Butalbital, aspirin, caffeine and codeine capsules
(90-521-579).
Charge: Products are unapproved new drugs.
Firm: Halsey Drug Company, Inc., Brooklyn, New York.
Filed: February 13, 1990 - U.S. District Court for the
Eastern District of New York; Civil #CV-90-0495,
FDC #65796.
----
Product: Frozen Shrimp (90-560-025).
Charge: Product is decomposed.
Firm: Gulf City Fisheries, Inc., Pascagoula, Mississippi.
Filed: February 6, 1990 - U.S. District Court for the
Southern District of Alabama; FDC #65805.
----
Product: Dog Food (90-541-077).
Charge: Adulterated - Product contains rodent filth.
Firm: Payless Drug Stores Northwest, Inc., Woodland, California.
Filed: January 30, 1990 - U.S. District Court for the Eastern
District of California at Sacramento; Civil #90-0128-EJG-EM,
FDC #65811.
----
Product: Canned Mushrooms (89-444-448).
Charge: Adulterated - Product contains staphylococcal enterotoxin.
Firm: Princeton International, Inc., Los Angeles, California.
Filed: January 17, 1990 - U.S. District Court for the Central
District of California; Civil #90-0258, FDC #65799.
----