Drug product
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
D-0360-2022
Product summary
- Event
- Event 89322
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
- Official record key
drug-enforcement:D-0360-2022
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: a) B1429436-110821, Exp 07/2022; B1429434-110821, Exp 11/2022; B1429435-110821, Exp 11/2022; B1279449-072021, Exp 07/2022; B1279457-072021, Exp 07/2022; B1279442-072021,Exp 07/2022; B1057718-012621, Exp 01/2022; B1057727-012621, Exp 01/2022; b) B1358139-092121, Exp 03/2022; B1424654-110421, B1437578-111421, Exp 05/2022
Distribution pattern: Product was distributed to two direct accounts in MI and PA.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications