Drug product
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
D-1093-2014
Product summary
- Event
- Event 67412
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2494 capsules
- Official record key
drug-enforcement:D-1093-2014
Official wording
Reason: CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Code information: Lot # 34017426A, Exp. 10/16.
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations