FDA recall D-0575-2023

Product

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05

Reason for recall

Lack of Assurance of Sterility: Malformed crimped collar seal

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-04-11

Report date

2023-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0575-2023