Recalls / Class III
Class IIID-0650-2016
Product
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
- Affected lot / code info
- Lot # 3063759, Exp.07/16
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 868 unit cartons (86,800 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-01-28
- FDA classified
- 2016-02-02
- Posted by FDA
- 2016-02-10
- Terminated
- 2016-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0650-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.