Drug product
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
D-0650-2016
Product summary
- Event
- Event 73170
- Status
- Terminated
- Classification
- Class III
- Quantity
- 868 unit cartons (86,800 tablets)
- Official record key
drug-enforcement:D-0650-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Code information: Lot # 3063759, Exp.07/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification