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
01/10/1996
ENFORCEMENT REPORT FOR 01/10/96
January 10, 1996 96-02
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Dotty's Donuts Cherry Donut Cake Mix, packaged
in 25 pound bags. Recall #F-104-6.
CODE Product manufactured between April and
September 1995.
MANUFACTURER Iowa Donut Supply Company, Des Moines, Iowa.
RECALLED BY Manufacturer, by telephone between October 24
and 27, 1995. FDA-initiated recall complete.
DISTRIBUTION Nebraska, Iowa, Illinois.
QUANTITY 2,375 pounds were distributed.
REASON Product contained FD&C Red #3 which was
canceled from the provisional listing as of
January 29, 1990.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Metronidazole, Rx oral synthetic antiprotozoal
and antibacterial agent, under the Zenith and
Goldline labels: (a) 250 mg in bottles of 100,
250, and 500; (b) 500 mg in bottles of 50 and
100. Recall #D-063/064-6.
CODE Lot numbers: (a) 2971-837 EXP B01/97, 2971-
833 EXP C10/96, 3528-706 EXP D10/96, 3528-706
EXP E10/96; (b) 3007-820V EXP A09/96, 3007-
820V EXP A09/96, 3007-824 EXP A11/96.
MANUFACTURER Zenith Laboratories, Inc., Cidra, Puerto Rico.
RECALLED BY Manufacturer, by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Lot #Configuration Amount Dosage
2971-833 bottles of 100'S 8731 250 mg
2971-837 bottles of 250'S 1217 250 mg
3528-706 bottles of 250'S 1404 250 mg
3528-706 bottles of 500'S 469 250 mg
3007-820V bottles of 50'S 394 500 mg
3007-820V bottles of 100'S 6000 500 mg
3007-824 bottles of 100'S 4859 500 mg.
Firm estimated that 2000 units of all lots
remained on market at time of recall
initiation.
REASON Superpotency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Cardizem CD (diltiazem HCl), packaged in the
following strengths and sizes: (a) 120 mg.
(90-capsule bottles); (b) 180 mg.(90-capsule
bottles); (c) 240 mg. (5,000-capsule bottles);
(d) 300 mg. (90-capsule bottles), used in the
treatment of hypertension.
Recall #D-056/059-6.
CODES Lot numbers and EXP dates: (a) P90160 8/97,
P90163, 8/97;
(b) P30528 7/97, P30529 7/97, P30530 8/97,
P30531 8/97, P30537 8/97, P30538 8/97;
(c) P40596 8/97, P40610 9/97; (d) P70264
8/97.
MANUFACTURER Hoechst Marion Roussel, Inc., Kansas City,
Missouri.
RECALLED BY Manufacturer, by telephone on November 2-3,
1995, followed by letter dated November 2,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 105,522/90-capsule bottles and
295/5,000-capsule containers were distributed.
REASONSeveral capsules may contain metal particles.
_______________
PRODUCT Bulk Magnesium Sulfate Anhydrous, in 200 pound
fiber drums, for drug use. Recall #D-060-6.
CODE SPH030 and SPH031.
MANUFACTURER Mallinckrodt Chemical, Inc., St. Louis,
Missouri.
RECALLED BY Manufacturer, by letter dated November 16,
1995. Firm-initiated recall complete.
-2- DISTRIBUTION Illinois, Missouri, Florida, New Jersey,
Indiana, Ohio, Georgia, Delaware, Puerto Rico,
Holland.
QUANTITY 61 drums were distributed.
REASON Product does not meet heavy metal
specifications.
_______________
PRODUCT Carbamide Peroxide 6.5% Ear Drops, 1/2 fluid
ounce plastic bottle, an OTC product used as
an aid to soften, loosen and remove excessive
earwax, distributed under the manufacturer's
(Clay-Park) and the following private labels:
Consumer Value Stores (CVS) [18 mo. & 24 mo.]
Goldline Laboratories [18 mo. & 24 mo.]
Thrifty Companies [18 mo. & 24 mo.]
Big B Discount Drugs [18 mo. & 24 mo.]
K & B Inc. [18 mo. & 24 mo.]
Rite Aid Dist. [24 month only]
American Drug Stores [18 mo. & 24 mo.]
(Osco label)
McKesson Drug Co. [18 mo. & 24 mo.]
(Valu-Rite label)
Hooks Drugs Inc. [24 month only]
H. L. Moore Drug Exchange [18 mo. & 24 mo.]
(Valumed label)
Thrift Drug Co. [18 mo. & 24 mo.]
(Treasury label)
Pay Less Drug Stores [18 mo. & 24 mo.]
Arbor Drug Inc. [18 mo. & 24 mo.]
Family Independent Pharmacy [18 mo. & 24 mo.]
Fay's Drug Stores [18 mo. & 24 mo.]
Pfeiffer Pharmaceuticals [18 mo. & 24 mo.]
Revco D.S. Inc. [18 mo. & 24 mo.]
Medicine Shoppe Int'l [18 mo. & 24 mo.]
Longs Drug Stores, Inc. [18 mo. & 24 mo.]
Brooks Drugs [18 month only]
Eckerd Drug Company [18 month only]
Kinney Drugs [18 month only]
Rugby Laboratories [18 month only]
Moore Medical [18 month only]
Recall #D-061-6.
CODES All lots with the 18 month and 24 month
expiration periods.
Lot #s (Exp. Date) for 24 month:
U302 (Nov 95), U429 (Dec 95), U895 (Feb 96),
V091 (Mar 96), V098 (Mar 96), V586 (May 96),
V744 (Jun 96), V754 (Jun 96), V937 (Jul 96),
W126 (Aug 96), W237 (Aug 96), W366 (Sep 96),
W722 (Oct 96), W730 (Oct 96), W954 (Nov 96),
X078 (Dec 96).
-3- Lot #s (Exp. Date) for 18 month:
AB007 (10/96), AB008 (10/96), AB009 (10/96),
AB027 (10/96), AB045 (11/96), AC230 (3/97),
AC294 (3/97), AC361 (3/97).
MANUFACTURER Clay-Park Labs, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letters mailed on December 6
and 27, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, South America, West
Indies.
QUANTITY 519,330 bottles of the lots with the 24 month
expiry period, and 536,739 bottles with the 18
month expiry period.
REASON Subpotency.
_______________
PRODUCT Fujisawa Cytarabine Injection, 20 mg/ml, Rx
antineoplastic sterile lyophilized powder for
reconstitution and intravenous powder used in
combination with other approved anticancer
drugs. Recall #D-062-6.
CODE Lot #4011979 EXP 7/96.
MANUFACTURER F.H. Faulding & Company, Ltd., Mulgrave, North
Victoria 3170, Australia.
RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by
letter dated December 29, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,263 vials were distributed; firm estimated
that less than 400 vials remained on the
market at time of recall initiation.
REASON Presence of visual silicone particulates.
_______________
PRODUCT (a) Cetacaine Topical Anesthetic Liquid, in 56
gram bottles, Rx, indicated for use to control
pain; (b) Cetacaine Topical Anesthetic
Ointment, in 37 gram jars, Rx, indicated for
use to control pain. Recall #D-065/066-6.
CODE Batch numbers: (a) 408 EXP 6/95, 409 EXP
12/95. (b) 641 EXP 6/95, 642 EXP 1/96.
MANUFACTURER Cetylite Industries, Inc., Pennsauken, New
Jersey.
RECALLED BY Manufacturer, by letters dated April 14, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,900 bottles of batch 408 and 1,982
bottles of batch 409; (b) 2,586 jars of batch
641 and 2,529 jars of batch 642 were
distributed; (a) firm estimated that 26
-4- bottles from batch 408 and 94 bottles from
batch 409; (b) 48 jars from batch 641 and 281
jars from batch 642 remained on market at time
of recall initiation.
REASON Products do not meet stability specifications.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT ASM Mattress and PSM Mattress:
(a) Alternating Pressure Mattress, ASM-
776/780; (b) Powered Low Air Loss Mattress,
PSM-176/180. Recall #Z-207/208-6.
CODE All serial numbers beginning with A5-, B5-,
C5-, D5-, and E5-. Serial numbers are located
on cell itself. Dates between January 1995
and approximately May 31, 1995 on under
penalty of law tag.
MANUFACTURER Gaymar Industries, Inc., Orchard Park, New
York.
RECALLED BY Manufacturer, by telephone between July 18,
1995 and August 11, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,880 units; (b) 38 units.
REASON Some of the lower cells of the mattress
systems exhibited internal separation of
button welds resulting in an observable
bulging effect of the mattress.
_______________
PRODUCT Sof.Care Bed Cushions, used for pressure ulcer
prevention and treatment: (a) Model SC-440;
(b) Model SC-460; (c) Model SC-427 when used
in conjunction with Continuous Inflation Pumps
Models SCM-3, CP-100, CP-200, and CP-300.
Recall #Z-261/263-6.
CODE (a & b) All lots; (c) Lots E1____ through
D5____.
MANUFACTURER Gaymar Industries, Inc., Orchard Park, New
York.
RECALLED BY Manufacturer, by letter dated July 7, 1995,
and b voice mail message sent July 6, 1995.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 49,930 units; (b) 36,598 units; (c) 5,000
units were distributed.
REASON The bed cushions may "balloon" or "expand"
beyond the cushions' normal dimensions if a
button weld failure were to occur and when
used with the SCN-or CP-300 continuous
inflation pump.
-5- _______________
PRODUCT 3M AVI Burette IV Administration Sets, Models:
8C1230, 8C2650, 8C1630, AJ2304; (b) IV Burette
Administration Set with interlink Injection
Ports, Models CJ4304, CK4303, CK2304.
Recall #Z-264/265-6.
CODE (a) Models 8C1230, 8C1630, 8C2650, AJ2304:
Recalled now: manufacturing dates of FEB95
and earlier in codes (for example, lot
MAR94K06 is recalled now).
Considered recalled one year after
manufacturing: all lots not recalled now (for
example lot MAR95T04 is recalled at the end of
February, 96);
(b) Manufacturing dates of NOV94 and earlier.
MANUFACTURER Korea Green Cross Corporation, Seoul, South
Korea.
RECALLED BY 3M Infusion Therapy, Arden Hills, Minnesota,
by letter December 8, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 500,000 sets; (b) 150,000 sets were
distributed.
REASON The sets leak at connections of the lower
piece of tubing to the y-piece and connections
of the lower piece of tubing to the luer
locks.
_______________
PRODUCT Horizon I.V. Administration Sets used with the
Horizon Modular Infusion System:
Catalog Numbers: CC3110; CC3115; CC3120;
CC3130; CC3131; CC3150; CC3152; CC3166;
CC3169; CC3180; NF3106; NF3110; NF3115;
NF3116; NF3120; NF3121; NF3140; NF3141;
NF3150; NF3152; NF3155; NF3160; NF3169;
NF3190; NF3191; V7400; V7401; V7405;
V7406; V7407; V7410; V7410-10;
V7410-SP01; V7410-SP02; V7412; V7413;
V7415; V7420; V7421; V7423; V7425;
V7430; V7430-SP01; V7435; V7440;
V7450; V7455; V7456; V7460; V7473;
V7483; V7490; V7495.
Recall #Z-267/319-6.
CODE All lot numbers.
MANUFACTURER McGaw of Puerto Rico, Inc., Sabana Grande,
Puerto.
RECALLED BY McGaw, Inc., Irvine, California, by letters
sent September 26, 1995. Firm-initiated
recall ongoing.
-6- DISTRIBUTION Nationwide and international.
QUANTITY 35,152 cases were distributed.
REASON The set tubing is being cut by the pump tube
pincher mechanism, and as a result, leakage of
medication or air entering the I.V. line can
occur.
_______________
PRODUCT Olympus brand Disinfectant Solution, for use
with Olympus Automated Blood Typing and
Clinical Chemistry Analyzers.
Recall #Z-320-6.
CODE Catalog #OPA2002, Lot numbers: 061295 EXP
12/95, 072495 EXP 1/96, 082095 EXP 2/96.
MANUFACTURER Decon Laboratories, Inc., Bryn Mawr,
Pennsylvania.
RECALLED BY Olympus America, Inc., (OAI), Melville, New
York, by letter sent on November 27, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 86 units were distributed.
REASON The disinfecting solution bottles are
ballooning and distended, and contain a dark
colored sediment.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Trakstar 18 PTCA Dilatation Catheter with SLX
Coating, Catalog #535-020, a balloon catheter
used to widen arteries during cardiac
catherization procedures. Recall #Z-260-6.
CODE Lot #40895302 only.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
RECALLED BY Manufacturer, by visit beginning November 20,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Indiana, Michigan, California, Arizona,
Massachusetts, Florida, Illinois.
QUANTITY 14 units were distributed.
REASON The incorrect dimensions are listed on the
side panel of the device's shelf packaging.
The front box label and the inner pouch are
labeled with the correct balloon dimensions of
2.0 mm (inflated balloon width) x 20 mm
(inflated balloon length). The mislabeled
side panel indicated dimensions of 3.0 mm x 30
mm.
-7- _______________
UPDATE Recall #Z-255/256-6, Quinton Instrument Q-710
Stress Electrocardiograph and Q-4500 Stress
Test System, which appeared in the January 3,
1996 Enforcement Report should read:
CODE: Serial numbers: (a) 101 through 181;
(b) 2171 through 2284 (serial numbers are non-
consecutive).
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ======
_______________
PRODUCT Hubbard poultry feeds, in 50 pound bags: (a)
23% Broiler Starter AM.0125 Granules Medicated
(Amprolium), (b) 20% Chick Starter AM.0125
(Amprolium). Recall #V-006/007-6.
CODE Lot Nos: (a) 10324806055; (b) 10124806055.
MANUFACTURER Hubbard Milling Company, Shipshewana, Indiana.
RECALLED BY Manufacturer, by telephone on June 7, 1995.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY (a) 63 bags; (b) 77 bags were distributed.
REASON Products were mistakenly manufactured with
Apralan 75 (75 gm/lb) instead of Amprolium 25%
(11.25 gm/lb).
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ======
_______________
PRODUCT Baciferm 50 Medicated Bacitracin Zinc Premix,
Type A Medicated Article, in 50 pound bags,
for use in poultry and livestock feeds.
Recall #V-006-6.
CODE Lot numbers: E523-1, E523-2, E530-1, E531-1,
E531-2.
MANUFACTURER Fort Dodge Laboratories, Fort Dodge, Iowa.
RECALLED BY Manufacturer, by letter on November 22, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Tennessee, Delaware, Arkansas, Alabama,
Minnesota, North Carolina.
QUANTITY 121,000 pounds were distributed.
REASON The active ingredient, bacitracin zinc was
contaminated with salinomycin.
MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Baxter " Single Use Only" 12 Foot Extension
Set, Product Code 5C4464, disposable supplies
for the HomeChoice Automated PD (Peritoneal
Dialysis) System. Safety Alert #N-006-6.
-8- CODE All lots.
MANUFACTURER Baxter Healthcare Corporation, Mountain Home
Arizona.
ALERTED BY Baxter Healthcare Corporation, McGaw Park,
Illinois, by letter December 12, 1995.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,750,000 sets were distributed;
firm estimated that 150,000 remained on market
at initiation of safety alert.
REASON Reuse of the "Single Use Only" 12 foot drain
line, and other disposable supplies for the
Automated Peritoneal Dialysis System, could
result in peritonitis.
-9-
END OF ENFORCEMENT REPORT FOR JANUARY 10, 1995. BLANK PAGES MAY
FOLLOW.
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