Drug recall D-1291-2020
Product
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
Reason for recall
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Lots and codes
Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
Recall details
- Recalling firm
- UNICHEM PHARMACEUTICALS USA INC, East Brunswick, NJ
- Quantity
- 190,992 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 26, 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.