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SafetyAlerts
January 17, 2002

Novartis Has Recalled Carbamazepine Tablets

Suffern, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said that Accumed Inc. has recalled Carbamazepine Tablets, Tegretol brand, 200 mg, in bottles of 100 Tablets and 1000 Tablets.

PRODUCT
Carbamazepine Tablets, Tegretol brand, 200 mg, in bottles of 100 Tablets (NDC 0083-0027-30) and 1000 Tablets (NDC 0083-0027-40), Recall # D-066-2.

CODE
Lot/code/expiration date:
124B0093 (bottles of 100s), NDC 0083-0027-30, APR 2002;
174D4344 (bottles of 1000s), NDC 0083-0027-40, FEB 2003;
234E9126 (bottles of 1000s), NDC 0083-0027-40, MAR 2004.

RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., Suffern, NY, by letter on 11/12/01. Firm initiated recall is ongoing.

REASON
Dissolution failure (at stability testing).

VOLUME OF PRODUCT IN COMMERCE
44, 212 bottles:
lot 124B0093 - 36,665 bottles;
lot 174D4344 - 3717 bottles;
lot 234E9126 - 3830 bottles.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
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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.