Class III
Terminated
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
- Recall Initiated
- September 28, 2016
- Posted
- November 16, 2016
- Recall Number
- D-0136-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46,472 unit dose blister cards (10 cards of 10 tablets each)
- Firm Location
- Rockford, IL, United States
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Distribution
Nationwide
Lot / Code Info
Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17
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