Drug product
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
D-0246-2021
Product summary
- Event
- Event 87152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44,256 bottles
- Official record key
drug-enforcement:D-0246-2021
Official wording
Reason: CGMP deviations.
Code information: AC05096, AC05098, and AC05099; Exp 10/31/2022
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP deviations