D-0829-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2020
- Initiation Date
- January 29, 2020
- Termination Date
- January 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19161600 units
Product Description
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 for Recall
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 Pattern
Distributed Nationwide in the US
Code Information
Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020