FDA-Drug2020-08-05Class III
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
Hazard
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Sold states
Nationwide USA
Affected count
3516 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1445-2020More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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