Recalls / Class II
Class IID-0013-2018
Product
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
- Affected lot / code info
- Lot 1274C151A, Exp 10/17
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 3,935 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-26
- FDA classified
- 2017-10-19
- Posted by FDA
- 2017-10-25
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0013-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.