Phenylephrine HCl recalled over sterility concerns

Recall date

March 13, 2019

Source

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

Official notice title

Advanced Pharma Inc. recalls Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL S…

Recall number

D-1028-2019

FDA classification

Class II

Brand / firm

Advanced Pharma Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404