Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured
Recalled November 16, 2016 · FDA recall D-0136-2017 · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint. · FDA Class III
Units
46,472 unit dose blister cards (10 cards of 10 tablets each)
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
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
Manufacturer(s)
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →