Provepharm Inc. recalls Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single un…

Recall date

January 21, 2025

Source

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

Recall number

D-0230-2025

FDA classification

Class I

Brand / firm

Provepharm Inc.

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Presence of Particulate Matter.

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 Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426