FDA recall D-1083-2020

Product

rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10

Reason for recall

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-03-16

Report date

2020-04-15

Termination date

2025-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2020