Recalls / Class III
Class IIID-0135-2017
Product
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
- Affected lot / code info
- Lot#: a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-28
- FDA classified
- 2016-11-10
- Posted by FDA
- 2016-11-16
- Terminated
- 2018-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0135-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.