FDA recall D-0230-2025

Provepharm Inc. · Class I · drug

Product

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

Reason for recall

Presence of Particulate Matter.

Distribution

Nationwide in the U.S.

Key facts

Status: Ongoing
Initiation date: 2025-01-21
Report date: 2025-02-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Collegeville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2025