March 2021 FDA Recall Candesartan by Macleods Pharma Usa Inc
D-0329-2021 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Macleods Pharma Usa Inc on March 22, 2021 for the product Candesartan. 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-0329-2021
Failed Impurities/Degradation Specifications
03-22-2021
04-21-2021
8015 packs
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.
Macleods Pharma 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
12-13-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
Batch or Lot Expiration Information
Lot# Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.
