Drug 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
D-1291-2020
Product summary
- Event
- Event 85764
- Status
- Terminated
- Classification
- Class III
- Quantity
- 190,992 bottles
- Official record key
drug-enforcement:D-1291-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Code information: Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications