Drug 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
D-0329-2021
Product summary
- Event
- Event 87607
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8015 packs
- Official record key
drug-enforcement:D-0329-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications