PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: April 21, 2021 Initiated: March 22, 2021 #D-0329-2021

Product Description

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

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Recalling Firm
Macleods Pharma Usa Inc
Units Affected
8015 packs
Distribution
Nationwide within the United States
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Macleods Pharma Usa Inc. Units affected: 8015 packs.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on April 21, 2021. Severity: Low. Recall number: D-0329-2021.