FDA recall D-0901-2018

Product

Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

Reason for recall

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-06-14

Report date

2018-07-11

Termination date

2019-02-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0901-2018