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Safety Alerts
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.

PRODUCT
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., Rockford, IL;
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., Rockford, IL;
ii) 100 tablet bottle, NDC #55953-947-40;
iii) 500 tablet bottle, NDC #55953-947-70.

Recall #D-421/422-9.  Class III

CODE
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.

MANUFACTURER
Novopharm Ltd., Toronto, Ontario, Canada.

RECALLED BY
Novopharm USA, Inc., Schaumburg, Illinois, by letters dated August 19 and 24, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.