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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 19, 1999

Novartis Pharmaceuticals Recalls Lamprene(r) Soft Gelatin Capsules

East Hanover, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Novartis Pharmaceuticals Corporation is recalling Lamprene(r) Soft Gelatin Capsules (Clofazimine), 50 mg, in 100 capsule bottles, because of disintegration failure.

Lamprene(r) Soft Gelatin Capsules are a prescription used in the treatment of lepromatous leprosy. (NDC#0028-0108-01).

Recall #D-064-9.

CODE
Lot #1028700 EXP 9/98.

MANUFACTURER
R.P. Scherer GMBH, Eberbach/Baden Germany.

RECALLED BY
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, by fax on June 16, 1998, followed by mail. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
27,523 bottles were distributed.

 

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.