FDA recall D-1092-2020

Product

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33

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-1092-2020