Recalls / Class II
Class IID-018-2014
Product
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
- Brand name
- Alprazolam
- Generic name
- Alprazolam
- Active ingredient
- Alprazolam
- Route
- Oral
- NDCs
- 0228-4019, 0228-4022, 0228-4024, 0228-4025
- FDA application
- ANDA078561
- Affected lot / code info
- Lot # 59380831, Exp. May 2014
Why it was recalled
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, N/A, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 756 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-09
- FDA classified
- 2013-11-22
- Posted by FDA
- 2013-12-04
- Terminated
- 2014-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-018-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.