FDA recall D-0424-2018

Product

100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC

Reason for recall

Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.

Distribution

Product was distributed to SC, FL, NY, NY,WA

Key facts

Status

Terminated

Initiation date

2018-02-05

Report date

2018-02-21

Termination date

2018-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0424-2018