Class III
Terminated
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
- Company
- Unichem Pharmaceuticals Usa Inc.
- Recall Initiated
- January 29, 2020
- Posted
- February 12, 2020
- Recall Number
- D-0829-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 19161600 units
- Firm Location
- East Brunswick, NJ, United States
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
Distributed Nationwide in the US
Lot / Code Info
Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020
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