Medications & Supplements/Prescription Drugs

RemedyRepack Cefixime 400 mg Capsules Recalled for Failed Impurities

Agency Publication Date: January 6, 2022

Summary

RemedyRepack Inc. has recalled Cefixime 400 mg capsules, an antibiotic used to treat bacterial infections. Approximately 716 bottles and 223 blister packs are affected because testing showed the medicine failed to meet safety standards for impurities and degradation. No injuries or illnesses have been reported in connection with this recall.

Risk

The drug failed quality specifications for impurities and degradation, which could mean the medication is less effective than intended or contains chemical byproducts. This could potentially lead to treatment failure or unexpected side effects.

What You Should Do

This recall affects Cefixime 400 mg capsules repacked by RemedyRepack Inc. and sold in 2-count bottles (NDC 70518-2749-02) or 2-count blister packs (NDC 70518-2749-03).
Identify if your medication is affected by checking the lot number and expiration date printed on your bottle or blister pack. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cefixime 400 mg capsule, 2-count bottle

Variants: 400 mg, Capsule

Lot Numbers:

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)

NDC:

70518-2749-02

Original Manufacturer: Ascend Labs, LLC, Montvale, NJ 07645

Product: Cefixime 400 mg capsule, 2-count blister pack

Variants: 400 mg, Capsule

Lot Numbers:

B1358139-092121 (Exp 03/2022)

B1424654-110421 (Exp 05/2022)

B1437578-111421 (Exp 05/2022)

NDC:

70518-2749-03

Original Manufacturer: Ascend Labs, LLC, Montvale, NJ 07645

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89322

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: Direct accounts in MI and PA

Manufactured In: United States

Units Affected: a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules

Distributed To: Michigan, Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Cefixime 400 mg capsules repacked by RemedyRepack Inc. and sold in 2-count bottles (NDC 70518-2749-02) or 2-count blister packs (NDC 70518-2749-03).

Identify if your medication is affected by checking the lot number and expiration date printed on your bottle or blister pack. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cefixime 400 mg capsule, 2-count bottle

Variants: 400 mg, Capsule

Lot Numbers:

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)

NDC:

70518-2749-02

Original Manufacturer: Ascend Labs, LLC, Montvale, NJ 07645

Product: Cefixime 400 mg capsule, 2-count blister pack

Variants: 400 mg, Capsule

Lot Numbers:

B1358139-092121 (Exp 03/2022)

B1424654-110421 (Exp 05/2022)

B1437578-111421 (Exp 05/2022)

NDC:

70518-2749-03

Original Manufacturer: Ascend Labs, LLC, Montvale, NJ 07645