FDA recall D-1291-2020

Product

Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01

Reason for recall

Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-05-26

Report date

2020-06-17

Termination date

2021-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1291-2020