Recalls / Class II
Class IID-1153-2014
Product
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
- Brand name
- Alprazolam
- Generic name
- Alprazolam
- Active ingredient
- Alprazolam
- Route
- Oral
- NDCs
- 0228-2027, 0228-2029, 0228-2031, 0228-2039
- FDA application
- ANDA074342
- Affected lot / code info
- Lot # 1826E131, Exp 04/2015
Why it was recalled
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
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
- 9447 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-02-10
- FDA classified
- 2014-03-10
- Posted by FDA
- 2014-03-19
- Terminated
- 2014-08-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1153-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.