FDA recall D-1155-2022

Product

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

Distribution

nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-06-03

Report date

2022-06-29

Termination date

2023-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

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