Recall: D-0829-2020

Class III - Minor Violations

Class IIIClassification

2020-01-29Initiated

TerminatedStatus

UNICHEM PHARMACEUTICALS USA INFirm

Product

Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, 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/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.

Distribution

Distributed Nationwide in the US

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