Drug recall D-1095-2014
Product
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.
Reason for recall
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Lots and codes
Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Quantity
- 35746 capsules
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 24, 2014
- Terminated
- October 8, 2014
Related products
- Hydroxyzine Pamoate – drug information
- NDC 0555-0323 Hydroxyzine Pamoate · Hydroxyzine Pamoate 25 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0302 Hydroxyzine Pamoate · Hydroxyzine Pamoate 50 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0324 Hydroxyzine Pamoate · Hydroxyzine Pamoate 100 mg/1 · Teva Pharmaceuticals USA, Inc.