Recalls / Class II
Class IID-0360-2022
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
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
- Distribution pattern
- Product was distributed to two direct accounts in MI and PA.
Timeline
- Recall initiated
- 2021-12-29
- FDA classified
- 2022-01-05
- Posted by FDA
- 2022-01-12
- Terminated
- 2022-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0360-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.