May 2020 FDA Recall Clonidine Hydrochloride by Unichem Pharmaceuticals Usa Inc
D-1291-2020 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc on May 26, 2020 for the product Clonidine Hydrochloride. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1291-2020
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
05-26-2020
06-17-2020
190,992 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
UNICHEM PHARMACEUTICALS USA INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
01-08-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
