PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: July 18, 2018 Initiated: July 5, 2018 #D-0925-2018

Product Description

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.

Details

Recalling Firm
Sanofi-Aventis U.S. LLC
Units Affected
3214 prefilled pens
Distribution
Nationwide
Location
Bridgewater, NJ

Frequently Asked Questions

What product 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. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 3214 prefilled pens.
Why was this product recalled?
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 18, 2018. Severity: Moderate. Recall number: D-0925-2018.