SUN PHARMACEUTICAL INDUSTRIES INC recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries
Recalled August 5, 2020 · FDA recall D-1445-2020 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine · FDA Class III
Units
3516 bottles
Sold at
Nationwide USA
Description
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Product
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →