Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Cefixime 400 mg capsule
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What 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
Affected NDCs
70518-2749-02
70518-2749-03
Compare with the code on your package — it is the most precise check available.
Drug: Cefixime
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cefixime NDC 70518-2749 |
400 mg/1 | Capsule Oral |
Remedyrepack INC. | Rx |
- Recalling firm
- RemedyRepack Inc.
- NDC code
- 70518-2749-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0360-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cefixime recalls
See all
Class II · Moderate risk
Cefixime for Oral Suspension USP 200 mg/5 mL
Failed Content Uniformity Specifications
Class II · Moderate risk
Cefixime for Oral Suspension 100mg/5mL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Class II · Moderate risk
Cefixime Capsules 400 mg
Failed Impurities/Degradation Specifications
Other recalls by RemedyRepack Inc.
All 2021 recalls
Class II · Moderate risk
Clindamycin HCl Capsule
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk
Clindamycin HCl
CGMP Deviations
Class II · Moderate risk
Carvedilol 25 mg Tablet
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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