Recalls / Class II
Class IID-0706-2017
Product
Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
- Affected lot / code info
- Code: 0378-5022-91 Lot: 3065878; Exp. 04/17
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 24,176 bottles (1,450,560 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-22
- FDA classified
- 2017-05-24
- Posted by FDA
- 2017-05-31
- Terminated
- 2017-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0706-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.