FDA recall D-1445-2020

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

Reason for recall

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2020-07-06

Report date

2020-08-05

Termination date

2023-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1445-2020