Drug recall D-0829-2020
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 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.
Lots and codes
Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020
Recall details
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC, East Brunswick, NJ
- Quantity
- 19161600 units
- Distribution
- Distributed Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 29, 2020
- Terminated
- January 8, 2021
Related products
- Clonidine Hydrochloride – drug information
- NDC 29300-137 Clonidine hydrochloride · Clonidine Hydrochloride .3 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-468 Clonidine hydrochloride · Clonidine Hydrochloride .1 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-136 Clonidine hydrochloride · Clonidine Hydrochloride .2 mg/1 · Unichem Pharmaceuticals (USA), Inc.