FDA recall D-0099-2023

Product

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-01-06

Report date

2023-01-18

Termination date

2024-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2023