Reported May 24, 2023 · Ongoing
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC,…
Sanofi-Aventis U.S. LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sanofi-Aventis U.S. LLC · 55 Corporate Dr · Bridgewater, NJ · 08807-1265
Is this the product you have?
- 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
- Lot codes and dates
Lot # 3F497BEXP 12-31-2025
- Amount recalled
- 51,325 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Malformed crimped collar seal
This product could cause temporary or reversible health problems — stop using it.
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