January 17, 2002Novartis Has Recalled Carbamazepine
Suffern, NY (SafetyAlerts)
- The Food and Drug Administration (FDA) said that Accumed Inc. has recalled
Tablets, Tegretol brand, 200 mg, in bottles of 100 Tablets and 1000 Tablets.
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.
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.
Novartis Pharmaceuticals Corp., Suffern, NY, by letter on 11/12/01. Firm
initiated recall is ongoing.
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.
Nationwide and Puerto Rico.