FDAFDA · Food and drugs·Recall number D-1095-2014
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.
Published March 12, 2014 · Recall initiated: January 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROXYZINE PAMOATE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide.
- UPC
- 0305550302025
- Lot
- Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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