FDA recall D-1087-2020

PharMEDium Services, LLC · Class II · drug

Product

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05

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-1087-2020