Drug product
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
D-1013-2019
Product summary
- Event
- Event 81946
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,281 UD cartons
- Official record key
drug-enforcement:D-1013-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Code information: Lots: 3095198, 3096266, 3098776, EXP 05-2019
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications