D-0136-2017 Class III Terminated
FDA drug recall D-0136-2017 was initiated by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) on September 28, 2016 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint. The recall status is terminated (terminated August 28, 2018). Affected quantity: 46,472 unit dose blister cards (10 cards of 10 tablets each).
Recall Details
- Product Type
- Drugs
- Report Date
- November 16, 2016
- Initiation Date
- September 28, 2016
- Termination Date
- August 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,472 unit dose blister cards (10 cards of 10 tablets each)
Product Description
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
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 Pattern
Nationwide
Code Information
Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17