Sanofi-Aventis U.S. LLC initiated a recall of Admelog, insulin lispro injection, on April 11, 2023. The recall is classified as Class II by the FDA.
The affected product is Admelog 100 units/mL (U-100), supplied in 3mL multi-dose vials, NDC 0024-5926-05. It is manufactured by Sanofi-Aventis U.S. LLC, a Sanofi company based in Bridgewater, NJ.
The stated reason for the recall is lack of assurance of sterility, attributed to a malformed crimped collar seal on the vials. This recall status is currently listed as ongoing.
A Class II classification indicates a specific level of regulatory concern as defined by the FDA, based on the reason given. This recall notice reflects reported facts about the product and packaging defect only. It does not state that any patient harm has occurred.
Insulin lispro remains an approved medication. This recall pertains specifically to the identified lot or lots affected by the described seal defect, as listed in FDA recall records.
Readers can consult the compound overview for additional context on insulin lispro.