Class III
Terminated
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
- Company
- Unichem Pharmaceuticals Usa Inc.
- Recall Initiated
- May 26, 2020
- Posted
- June 17, 2020
- Recall Number
- D-1291-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 190,992 bottles
- Firm Location
- East Brunswick, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
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