Admelog Solostar recalled over temperature-control failures

Recall date

July 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sanofi-Aventis U.S. LLC recalls Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per…

Recall number

D-0925-2018

FDA classification

Class II

Brand / firm

Sanofi-Aventis U.S. LLC

Sold / distributed

Nationwide

Why it was recalled

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00