Advanced Pharma Inc. recalls Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as…

Recall date

November 29, 2018

Source

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

Recall number

D-0347-2019

FDA classification

Class I

Brand / firm

Advanced Pharma Inc.

Sold / distributed

Heath care facilities in NM, TX, and OH

Why it was recalled

Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.