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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: a) B1429436-110821, Exp 07/2022; B1429434-110821, Exp 11/2022; B1429435-110821, Exp 11/2022; B1279449-072021, Exp 07/2022; B1279457-072021, Exp 07/2022; B1279442-072021,Exp 07/2022; B1057718-012621, Exp 01/2022; B1057727-012621, Exp 01/2022; b) B1358139-092121, Exp 03/2022; B1424654-110421, B1437578-111421, Exp 05/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- RemedyRepack Inc.
- Reason for Recall:
- Failed Impurities/Degradation Specifications
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot #: a) B1429436-110821, Exp 07/2022; B1429434-110821, Exp 11/2022; B1429435-110821, Exp 11/2022; B1279449-072021, Exp 07/2022; B1279457-072021, Exp 07/2022; B1279442-072021,Exp 07/2022; B1057718-012621, Exp 01/2022; B1057727-012621, Exp 01/2022; b) B1358139-092121, Exp 03/2022; B1424654-110421, B1437578-111421, Exp 05/2022
Distribution:
Distributed in: MI, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0360-2022
Related Recalls
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
CGMP Deviations
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.