September 22, 1999
Acyclovir Tablets Recalled by Novopharm USA, Inc.
Schaumburg, IL (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Novopharm USA, Inc. is recalling Acyclovir
Tablets because of a softening and cracking of tablets.
Acyclovir Tablets, Rx oral antiviral drug for the
acute treatment of herpes zoster, initial episodes and management of recurrent episodes of
genital herpes, and the treatment of chickenpox, packaged in unit dose and bottles of 100
and 500 tablets under the following labels:
a) 400 mg. Tablets:
i) 100 tablets/unit dose, NDC #51079-877-20, Distributed by UDL Laboratories, Inc.,
ii) 100 tablet bottle, NDC #55953-943-40;
iii) 500 tablet bottle, NDC #55953-943-7;
b) 800 mg. Tablets:
i) 100 tablets/unit dose, NDC #51079-878-20, Distributed by UDL Laboratories, Inc.,
ii) 100 tablet bottle, NDC #55953-947-40;
iii) 500 tablet bottle, NDC #55953-947-70.
Recall #D-421/422-9. Class III
The following lot numbers will be followed with letter sublot designations, i.e.
113569A, on the package labels:
a) 400 mg.: 113569, 108227
b) 800 mg.: 108235, 108772, 113570, 113571, 113572.
Novopharm Ltd., Toronto, Ontario, Canada.
Novopharm USA, Inc., Schaumburg, Illinois, by letters dated August 19 and 24, 1999.
Firm-initiated recall ongoing.
2,212 unit dose cartons, 105 500-tablet bottles and 12,737 100-tablet bottles of
400 mg. tablets and 1,602 unit dose cartons, 759 500-tablet bottles and 8,838 100-tablet
bottles of 800 mg. tablets were distributed; firm estimates that 40% of the product
remains on the market.
Questions concerning this recall may be directed
to the Food and Drug Administration at 1-800-INFO-FDA.
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