Recall: D-1291-2020

Class III - Minor Violations

Class IIIClassification

2020-05-26Initiated

TerminatedStatus

UNICHEM PHARMACEUTICALS USA INFirm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.