Recalls / Class II
Class IID-1093-2014
Product
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02
- Brand name
- Hydroxyzine Pamoate
- Generic name
- Hydroxyzine Pamoate
- Active ingredient
- Hydroxyzine Pamoate
- Route
- Oral
- NDCs
- 0555-0302, 0555-0323, 0555-0324
- FDA application
- ANDA088487
- Affected lot / code info
- Lot # 34017426A, Exp. 10/16.
Why it was recalled
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 2494 capsules
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-01-24
- FDA classified
- 2014-02-28
- Posted by FDA
- 2014-03-12
- Terminated
- 2014-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1093-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.