FDA-Drug2021-04-21Class III

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

Macleods Pharma Usa Inc
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide within the United States
Affected count
8015 packs
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0329-2021

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