100 mcg / mL Phenylephrine HCl Injection recalled over sterility concerns

Recall date

February 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0424-2018

FDA classification

Class II

Brand / firm

PharMEDium Services, LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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