Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0360-2022
Event ID89322
DistributionProduct was distributed to two direct accounts in MI and PA.
Quantitya) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
Recall ReasonFailed Impurities/Degradation Specifications
Drug ClassificationClass II
Drug Code Info20220112
Recall Initiation Date20211229
Report Date20220112
Classification Date20220105
Address625 Kolter Dr Ste 4
Indiana, PA 15701-3571
United States
Recalling FirmRemedyRepack Inc.
Initial Notification Letter
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