Recall D-0360-2022
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
Recall D-0360-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0360-2022 |
Event ID | 89322 |
Distribution | Product was distributed to two direct accounts in MI and PA. |
Quantity | a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules |
Recall Reason | Failed Impurities/Degradation Specifications |
Drug Classification | Class II |
Drug Code Info | 20220112 |
Recall Initiation Date | 20211229 |
Report Date | 20220112 |
Classification Date | 20220105 |
Address | 625 Kolter Dr Ste 4 Indiana, PA 15701-3571 United States |
Recalling Firm | RemedyRepack Inc. |
Initial Notification | Letter |
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