FDA recall D-0925-2018

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2018-07-05

Report date

2018-07-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0925-2018