D-0360-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 12, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- April 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Product was distributed to two direct accounts in MI and PA.
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