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, ND

FDA recall notice · announced June 17, 2020 · Unichem Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
Quantity: 190,992 bottles
Status: Terminated
Products in this recall event:
- 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 P (D-1291-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.