Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls 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
Recalled November 16, 2016 · FDA recall D-0135-2017 · 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 15 month timepoint. · FDA Class III
Units
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)
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
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
Manufacturer(s)
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →