Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (s...
FDA Recall #D-0230-2025 — Class I — January 21, 2025
Product Description
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.
Recalling Firm
Provepharm Inc. — Collegeville, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
24640 vials
Distribution
Nationwide in the U.S.
Code Information
Lot# 24020027, Exp Date: 12/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated