On July 5, 2018, Sanofi-Aventis U.S. LLC initiated a Class II recall of Admelog Solostar (insulin lispro injection), 100 units/mL (U-100). The recall applies to physician sample pens, packaged as 3mL prefilled pens, one pen per box, marked "Physician Sample - Not For Sale," under NDC 0024-5925-00.
The reason given for the recall is temperature abuse. According to the recall notice, product samples of Admelog may not have been shipped at the proper temperature. Sanofi-Aventis U.S. LLC, based in Bridgewater, NJ, is listed as the recalling firm.
The FDA classification for this action is Class II. The recall status is listed as ongoing. This information is drawn directly from the recall record identified as D-0925-2018.
This recall action pertains to specific physician sample units of Admelog and the stated shipping temperature concern. No additional details beyond the classification, reason, firm, and status have been provided in this record.
Readers can consult the compound overview for further context on insulin lispro.