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Recall Observatory FDA recall evidence

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

May 26, 2020

Class III

Product summary

Firm
UNICHEM PHARMACEUTICALS USA INC
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications