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
01/17/1996
ENFORCEMENT REPORT FOR 01/17/96
January 17, 1996 96-03
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT On the Spot brand Acne Treatment Creams, OTC
drugs in 0.75 ounce tubes: (a) Vanishing
Formula; (b) Tinted Formula.
Recall #D-067/068-6.
CODE Lot numbers: (a) 1G5 EXP 8/97;
(b) 1J5 EXP 9/97.
MANUFACTURER Packaging Advantage Corporation, Los Angeles,
California.
RECALLED BY Neutrogena Corporation, Los Angeles,
California, by letter on October 11, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 8,307 dozen tubes; (b) 3,475 dozen tubes
were distributed.
REASON Presence of Pseudomonas cepacia.
_______________
PRODUCT Indomethacin Sustained Release Capsules USP,
75 mg, Rx oral nonsteroidal anti-inflammatory
used in treatment of moderate to severe
rheumatoid arthritis. Recall #D-072-6.
CODE Lot numbers: 4230133 and 4315115.
MANUFACTURER Inwood Laboratories, Inc., Inwood, New York.
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills,
Illinois (repacker), by letter dated May 17,
1995. Firm-initiated recall complete.
DISTRIBUTION Missouri, New Mexico, Wyoming, New Jersey,
Washington, D.C., Michigan, Texas, Illinois,
Colorado.
QUANTITY 73 bottles of 14 capsules and 31 bottles of 10
capsules were distributed.
REASON Product does not meet dissolution
specifications.
_______________
PRODUCT Searle Calan Tablets, Verapamil Hydrochloride
(a) 40 mg, in 100 tablet bottles; (b) 80 mg,
in 100, 500, and 1000 tablet bottles, an
immediate action Rx oral calcium slow-channel
blocker for treatment of angina arrhythmias
and essential hypertension.
Recall #D-073/074-6.
CODE (a) 3K044, 4F050, 4L051, 4P052, 4P052A;
(b) 3P455, 4B457, 4C458, 4C459.
MANUFACTURER G.D. Searle & Company, Caguas, Puerto Rico.
RECALLED BY G.D. Searle & Company, Skokie, Illinois, by
letter dated January 8, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 98,405 100-tablet bottles; (b) 58,974 100-
tablet bottles, 1,000 500-tablet bottles, and
5,453 1000-tablet bottles were distributed;
firm estimated that 10 percent of the product
remained on market at time of recall
initiation.
REASON Products may not meet dissolution
specifications.
_______________
PRODUCT Novopharm Piroxicam Capsules, USP, 20 mg, Rx
oral anti-inflammatory/analgesic, in bottles
of 100 capsules. Recall #D-075-6.
CODE Lot #5515240.
MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada.
RECALLED BY Novopharm, Inc., Schaumburg, Illinois, by
letter dated January 9, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,743 bottles were distributed; firm estimated
that very little if any of the product
remained on market at time of recall
initiation.
REASON product does not meet dissolution
specifications.
-2- _______________
PRODUCT Oxygen USP in steel and aluminum high pressure
cylinders, sizes E, D, B, M6, and N.
Recall #D-076-6.
CODE Al lot numbers beginning with 07, 08, 09, 10,
11, and 12.
MANUFACTURER Home Oxygen Medical Equipment, Inc., Oswego,
New York.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY Several hundred cylinders were distributed.
REASON Current good manufacturing practice (CGMP)
deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III =========
_______________
PRODUCT Novadyne Expectorant, antitussive,
decongestant in 4 fluid ounce, pint, and
gallon size containers, under the H N Norton
and Goldline labels. Recall #D-069-6.
CODE Lot #6564 EXP 12/95.
MANUFACTURER Zenith Goldline - Shreveport, Shreveport,
Louisiana.
RECALLED BY Manufacturer, by letter dated December 5,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Norton: 11,811 4-fluid ounce size;
1,986 pint size; 95 gallons size
Goldline: 13,980 4-fluid ounce size
5,688 pint size were distributed.
REASON Product does not meet Codeine Phosphate
specifications through expiration date.
_______________
PRODUCT Chemdal HD Liquid, antitussive, decongestant,
in pint and gallon size containers, under the
H N Norton, Goldline, and Major labels.
Recall #D-070-6.
CODE Lot #7724.
MANUFACTURER Zenith Goldline Pharmaceuticals, Shreveport,
Louisiana.
RECALLED BY Manufacturer, by letter on December 6, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY HN Norton/LuChem: 1,976 pints and 398 gallons
Goldline: 2,447 pints
Major: 6,621 pints were distributed.
REASON Product does not meet Phenylephrine HCl
specifications through expiration date.
-3- _______________
PRODUCT Isoniazid Tablets USP, 100 mg, Rx oral anti-
tuberculin, in bottles of 30 and 100 tablets.
Recall #D-071-6.
CODE Lot numbers: 2231133 and 4046112.
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills,
Illinois (repacker), by letters dated April
27, 1995 and November 27, 1995. Firm-
initiated recall complete.
DISTRIBUTION California and Georgia.
QUANTITY 59 bottles of 30 tablets and 6 bottles of 100
tablets were distributed.
REASON Product does not meet dissolution
specifications at the 48 and 60 month test
intervals.
-4-
END OF ENFORCEMENT REPORT FOR JANUARY 17, 1996. BLANK PAGES MAY
FOLLOW.
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