Recalls / Class II
Class IID-1091-2014
Product
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
- Brand name
- Alprazolam
- Generic name
- Alprazolam
- Active ingredient
- Alprazolam
- Route
- Oral
- NDCs
- 0228-3083, 0228-3084, 0228-3087, 0228-3086
- FDA application
- ANDA078056
- Affected lot / code info
- Lot #: 57617531, Exp 03/14
Why it was recalled
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 5,148 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-02-04
- FDA classified
- 2014-02-28
- Posted by FDA
- 2014-03-12
- Terminated
- 2015-01-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1091-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.