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

FDA recall notice · announced April 21, 2021 · Macleods Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide within the United States
Lot/code information: Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.
Quantity: 8015 packs
Status: Terminated
Products in this recall event:
- 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.), In (D-0329-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.