FDA-Drug2022-06-29Class II

Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

Sold states
nationwide within the United States
Affected count
4608 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1155-2022

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