PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: June 29, 2022 Initiated: June 3, 2022 #D-1155-2022

Product Description

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.

Reason for Recall

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

Details

Units Affected
4608 bottles
Distribution
nationwide within the United States
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 4608 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Which agency issued this recall?
This recall was issued by the FDA Drug on June 29, 2022. Severity: Moderate. Recall number: D-1155-2022.