Drug 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
D-0706-2017
Product summary
- Event
- Event 76922
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,176 bottles (1,450,560 tablets)
- Official record key
drug-enforcement:D-0706-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Code: 0378-5022-91 Lot: 3065878; Exp. 04/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications