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
03/19/1991
FDA Enforcement for the week of March 20, 1991
FDA ENFORCEMENT REPORT
FOR MARCH 20, 1988
March 20, 1991
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: "The Lil' One" brand Gum Ball Candy, 1/4" diameter, assorted
colors of red, yellow, blue and pink, 1 to 2 oz. in a
3.5" tall plastic dispenser with 24 dispensers each in
individual display boxes. Recall #F-229-1.
Code: Each shipping and master carton for gum ball candy
dispensers in display boxes has in black ink
P.O. #2281 *** item 6500. Shipping and master cartons for
candy dispensers in blister packs have printed in black ink
P.O. #2300 *** item 6600.
-1-
Manufacturer: Topco Industrial Company, Ltd., San Po Kong, KLN, Hong Kong.
Recalled by: Jolly Good Industries, Inc., Boynton Beach, Florida, by
letter September 21, 1990. Firm-initiated recall ongoing.
Distribution: California, Illinois, New York, Florida, Michigan,
Maryland, New Jersey, Tennessee, Virginia, Vermont,
Wyoming, Georgia, Colorado, Ohio, South Carolina, Missouri,
North Carolina.
Quantity: 6,000 candy dispensers were distributed.
Reason: Product contains Cochineal Red A, an unapproved color
for food use.
----
Product: Harlequin Vanilla, Chocolate, and Strawberry Ice Cream packed
in one half gallon paperboard carton. Recall #F-289-1.
Code: 1/11/92 0905. The military time of day is also printed
as part of the lot code.
Manufacturer: H.P. Hood Inc., Suffield, Connecticut.
Recalled by: Stop & Shop Supermarket Company, Boston, Massachusetts,
by electronic mail message January 12, 1991 and by
press release February 13, 1991. Firm-initiated recall
ongoing.
Distribution: Massachusetts, Rhode Island, Connecticut, New York.
Quantity: 571 cases (4 cartons/case) were distributed.
Reason: Product is contaminated with ammonia.
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Product: Bottled water in one gallon plastic bottles:
(a) Newton Valley Distilled Drinking Water;
(b) Newton Valley Artesian Water. Recall #F-290/291-1.
Code: (a) A09100; (b) All lots.
Manufacturer: Newton Vallety, Ltd., Manitowoc, Wisconsin.
Recalled by: Manufacturer, by telephone on or about December 24, 1990
followed by letter December 27, 1990. Firm-initiated
recall ongoing.
Distribution: Wisconsin, Illinois.
Quantity: (a) 840 cases (6 gallons/case); (b) 1,700 cases
were distributed.
Reason: Product is contaminated with a chemical odor and taste.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: German style potato salads in 7 pound cans:
(a) Roundy's German Style Potato Salad;
(b) GFS Gordon Food Service German Style Potato Salad;
(c) Reinhart brand German Potato Salad.
Recall #F-286/288-1.
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Code: Lot #GPC/39339.
Manufacturer: Aunt Nellie's Farm Kitchen's Inc., Clyman, Wisconsin.
Recalled by: Manufacturer, by letter January 14, 1991. Firm-initiated
recall ongoing.
Distribution: Michigan, Wisconsin.
Quantity: 899 cases (6 cans/case) were distributed; firm estimates
none remains on the market.
Reason: Swollen cans due to inadequate interior can coating.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Parmed brand Methocarbamol 750 mg Tablets, in bottles
of 100, an Rx muscle relaxant. Recall #D-272-1.
Code: Lot #6038-71 EXP 10/93.
Manufacturer: Pioneer Pharmaceuticals, Irvington, New Jersey.
Recalled by: Manufacturer, by letter January 29, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 432 bottles were distributed.
Reason: A portion of the lot (2 bottles) labeled as
methocarbamol 750 mg tablets contained indomethacin 25 mg
tablets.
----
Class III -
Product: Robitussin Night Relief Cold Formula, in 4 ounce bottles,
an OTC cough/cold product. Recall #D-273-1.
Code: Lot #90-21-9 EXP 8/92.
Manufacturer: A.H. Robins Company, Richmond, Virginia.
Recalled by: Manufacturer, by letter on or about February 25, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 118,320 bottles were distributed.
Reason: The acetaminophen ingredient was found subpotent.
----
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Product: Conjugated Estrogen Tablets USP (a) 0.3 mg; (b) 0.625 mg;
(c) 1.25 mg, in bottles of 100 or 1,000 tablets, an Rx
drug used for treating estrogen deficiencies in post-
menopausal women, under the following labels:
Aligen, Best, Bioline, Duramed, Genetco, Geneva,
Glenlawn, Goldline, Harper, H.L. Moore, Major, Martee,
Mutual, Parmed, Purepac, Qualitest, Rugby, Schein, Town
Paulsen, Texas Drug Reps, and URL. Recall #D-274/276-1.
Code: All lots of 1990 production.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter mailed February 28, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates that 78 lots consisting of approximately
950,000 tablets each remain in distribution.
Reason: Product may fail USP dissolution specifications.
----
Product: Oxygen, USP, in size "E" Compressed Gas Aluminum Cylinders.
Recall #D-277-1.
Code: Cylinders were filled between 11-1-90 and 2-14-91.
Manufacturer: Mountain Air Services Inc., Pennington Gap, Virginia
(repacker/responsible firm).
Recalled by: Repacker, by telephone February 21, 1991. Firm-
initiated recall ongoing.
Distribution: Virginia.
Quantity: 15 cylinders.
Reason: Current good manufacturing practice deficiencies.
----
Product: Brodspec brand of Tetracycline Hydrochloride Capsules
USP, 500 mg, in 1,000 capsule bottles, an Rx
antibiotic. Recall #D-278-1.
Code: Lot #9B09K EXP 9/92.
Manufacturer: Halsey Drug Co., Inc., Brooklyn, New Jersey.
Recalled by: C.O. Truxton, Inc., Camden, New Jersey, by telephone
December 5, 1990. Firm-initiated field correction complete.
Distribution: New Jersey, Delaware, Pennsylvania.
Quantity: 5 bottles were distributed.
Reason: Recalling firm relabeled product with expiration date
of 9/92 instead of 8/92.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: CPI Delta TRS DDD, Dual-Chamber Pulse Generator (pacemaker),
Multiprogrammable Model 937. Recall #Z-359-1.
An extension of Recall #Z-194/195-1 which appeared
in the February 20, 1991 Enforcement Report.
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Code: Serial numbers: 713551-713560, 713547-713549, 747051,
713550, 713592.
Manufacturer: Cardiac Pacemakers, Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by letter February 18, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 13 units were distributed.
Reason: Pacemaker may exhibit early and rapid battery depletion
with a corresponding reduction in pulse amplitude. In
addition, the potential exists for the device to go to
an immediate "no output condition" if the capacitor fails.
----
EXTENSION: (a) CPI Vista 4 Pacemaker Model 443; (b) CPI VISTA T
Pacemaker, Model 445 Multiprogrammable Pulse Generator
(single chamber pacemakers), Recall #Z-194/195-1 which
appeared in the February 20, 1991 Enforcement Report has
been extended to include serial numbers:
(a) 726672 - 726681; (b) 726817, 726857, 726882-726886,
726982-726991, 726977-726981, 730224.
----
Class II -
Product: (a) Fasteeth Powder Dental Adhesive (may or may not say
"Advanced Formula"), plastic container, 3/4 oz, 1.75 oz,
and 3.0 oz sizes;
(b) Extra Hold Fasteeth Dental Adhesive Powder, (may or
may not say "for lowers and uppers too!"), plastic
container, 1.6 oz and 2.7 oz size. Recall #Z-255/256-1.
Code: All stock numbers except 76344, 76854, 76406 (2.7 oz);
76343, 76652 (1.6 oz); 76475, 76825, 24811 (.75 oz);
76346, 76405, 76824 (2.7 oz improved extra hold);
76345, 76404, 76823 (improved extra hold).
Manufacturer: Richardson-Vicks, Inc., Greensboro, North Carolina.
Recalled by: Richardson-Vicks, Inc., Shelton, Connecticut, by
telephoning and mailing recall packets between January 18
and 25, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 55,000 units remain on the market.
Reason: Product is contaminated with benzene.
----
Product: Precision Medical Inc., Flow Alert Pressure Relief Valve
and Flow Indicator, an audible pressure relief valve that
is attached to a flowmeter and relieves pressure build up
due to tubing occlusion:
(a) Model 8001 (without chain) and
Model 8001C (with chain);
(b) Model 1201 (without chain) and Model 1201C (with
chain. Recall #Z-343/344-1.
-5-
Code: Units shipped between 1/1/90 and 8/17/90.
Manufacturer: Southern Tier Plastics Inc., Binghamton, New York.
Recalled by: Medical Fittings, Inc./Precision Medical, Inc.,
Northampton, Pennsylvania, by letter October 26, 1990.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: (a) 268 units; (b) 634 units were distributed.
Reason: The device may develop stress cracks, that can cause
small leakage of oxygen.
----
Product: Sterile, Disposable, Hesung Scalp Vein Sets,
intravascular administration used to administer fluids
from a container to a patient's vascular system through a
needle or catheter inserted into a vein:
(a) Size 21G x 3/4"; (b) Size 22G x 3/4";
(c) Size 23G x 3/4". Recall #Z-356/358-1.
Code: Lot numbers: (a) P0850; (b) P0851; (c) P0852.
Manufacturer: Hesung Medical Supply Co., Ltd., Seol, Korea.
Recalled by: Surgix, Inc., Ronkonkoma, New York, by letter
November 1, 1990. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 184,800 sets were distributed, FDA estimates less than
10 percent remains on the market.
Reason: The package seals are defective, thus compromising package
sterility.
----
Product: Cyto-Stat/Coulter Clone T4-FITC/5B4-RD1 Liquid Murine
Monoclonal Antibody, 50 test (0.5 ml), intended for
research use only in the study of cell surface antigens
and other cell markers. Recall #Z-439-1.
Code: 2230A073.
Manufacturer: Coulter Immunology, Division of Coulter Corporation,
Hialeah, Florida.
Recalled by: Manufacturer, by letter January 24, 1991. Firm-initiated
recall ongoing.
Distribution: Massachusetts, Illinois, Minnesota, Rhode Island, Texas,
California, Maryland, New Jersey, Louisiana, England,
Italy, Portugal, Brazil.
Quantity: 53 bottles were distributed.
Reason: Product was marketed labeled "for in-vitro diagnostic use"
before the product received 510(k) approval.
----
Product: Atrial Bloodline 8 mm Pump Segment, used in conjunction
with dialysis machine only. Recall #Z-443-1.
Code: Catalog #03-9221-7, Lot #ROL089.
Manufacturer: Erika of Texas, National Medical Care Medical Products
Division, McAllen, Texas.
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Recalled by: National Medical Care, Medical Products Division, Rockleigh,
New Jersey, by telephone January 9-10, 1991 followed by
letter January 11, 1991. Firm-initiated recall ongoing.
Distribution: Ohio, Michigan, Wisconsin, Connecticut, Virginia.
Quantity: 5,796 pieces (483 cases) were distributed; firm
estimates 300 pieces (25 cases) remain on the market.
Reason: The product may leak.
----
Product: Olbert Catheter System for Ureteral Dilation, an Rx
sterile device packaged on plastic tray in paper/plastic
sleeve; system contains catheter with balloon plus syringe;
Recall #Z-444-1.
Code: Batch #771005, Sterilization Lot #5260, Sterilization
date 10/24/90; Catalog #751230 EXP 10/24/93
Manufacturer: Meadox Surgimed A/S, Stenlose, Denmark.
Recalled by: Meadox Surgimed, Inc., Oakland, New Jersey, by telephone
and by letter January 23, 1991. Firm-initiated recall
ongoing.
Distribution: Missouri, California, Florida, Illinois, Indiana,
North Carolina, Texas, Wisconsin.
Quantity: 21 systems were distributed; firm estimates none remains
on market.
Reason: The end flap of the pouch package may not be sealed. This
may compromise the sterility of the device.
----
Product: Statif Interface Boards used in model series 500
Sophy X-ray Cameras. Recall #Z-445-1.
Code: Serial numbers less than 1000.
Manufacturer: Sopha Medical Systems, Buc, France.
Recalled by: Sopha Medical Systems, Columbia, Maryland, by visit
beginning August 14, 1990. Firm-initiated field correction
complete.
Distribution: Nationwide.
Quantity: 61 interface boards were distributed.
Reason: The Statif Boards may exhibit sensitivity to
electrostatic charges thus causing unrequested head
movement (interfaced with the gantry).
----
Product: Becton Dickinson Easy Draw Syringe, 1 cc with precision
glide permanently attached needle (25G 5/8 sterile single
use). Recall #Z-446-1.
Code: Reorder #5590, lot numbers 9D079 and 9D080.
Manufacturer: Becton Dickinson, Holdrege, Nebraska.
Recalled by: Becton Dickinson, East Rutherford, New Jersey, by
telephone in June 1990 and by letter dated June 22, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Honduras.
-7-
Quantity: 474,500 units were distributed.
Reason: The barrel of the syringe was imprinted with the wrong
scales.
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Class III -
NONE
VETERINARY PRODUCTS
NONE