Class II · Moderate risk
Myxredlin
CGMP Deviations
Admelog (Insulin Lispro)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Malformed crimped collar seal
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Affected NDC
0024-5926-05
Compare with the code on your package — it is the most precise check available.
Drug: Insulin Category: Diabetes Medication
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 |
|---|---|---|---|---|
| Admelog insulin lispro NDC 00024-5926 |
100 U/mL | Injection, Solution Intravenous|subcutaneous |
Sanofi-Aventis U.S. LLC | Rx |
- Recalling firm
- Sanofi-Aventis U.S. LLC
- NDC code
- 0024-5926-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0575-2023 · 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.
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CGMP Deviations
Class I · High risk
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Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Class I · High risk
Humalog KwikPen
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Other recalls by Sanofi-Aventis U.S. LLC
All 2023 recalls
Class II · Moderate risk
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Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class II · Moderate risk
Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
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