Drug product
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.
D-1095-2014
Product summary
- Event
- Event 67412
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35746 capsules
- Official record key
drug-enforcement:D-1095-2014
Official wording
Reason: CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Code information: Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16.
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations