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
Reported: January 12, 2022 Initiated: December 29, 2021 #D-0360-2022
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
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
- Distribution
- Product was distributed to two direct accounts in MI and PA.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by RemedyRepack Inc.. Units affected: a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 12, 2022. Severity: Moderate. Recall number: D-0360-2022.
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