Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the…
Reason Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Sun Pharmaceutical Industries INCNDC 57664-783-86D-1445-2020
Reason Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month…
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)NDC 51079-882-20D-0136-2017
Reason Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month…
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)NDC 51079-881-20D-0135-2017