RemedyRepack Inc.: Drug Recall
Recall #D-0360-2022 · 12/29/2021
Class II: Risk
Recall Details
- Recall Number
- D-0360-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- RemedyRepack Inc.
- Status
- Terminated
- Date Initiated
- 12/29/2021
- Location
- Indiana, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
Reason for Recall
Failed Impurities/Degradation Specifications
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
Distribution Pattern
Product was distributed to two direct accounts in MI and PA.
Other Recalls by RemedyRepack Inc.
- Class II: Risk 04/22/2025
- Class II: Risk 03/24/2025
- Class II: Risk 01/24/2025
- Class II: Risk 12/02/2024
- Class II: Risk 06/26/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.