Drug product
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
D-0136-2017
Product summary
- Event
- Event 75295
- Status
- Terminated
- Classification
- Class III
- Quantity
- 46,472 unit dose blister cards (10 cards of 10 tablets each)
- Official record key
drug-enforcement:D-0136-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Code information: Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification