FDA-Drug2022-01-12Class II
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
RemedyRepack Inc.
Hazard
Failed Impurities/Degradation Specifications
Sold states
Product was distributed to two direct accounts in MI and PA.
Affected count
a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0360-2022Don't want to check this manually?
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