PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: February 26, 2025 Initiated: January 21, 2025 #D-0230-2025

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.

Details

Recalling Firm
Provepharm Inc.
Units Affected
24640 vials
Distribution
Nationwide in the U.S.
Location
Collegeville, PA

Frequently Asked Questions

What product 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. Recalled by Provepharm Inc.. Units affected: 24640 vials.
Why was this product recalled?
Presence of Particulate Matter.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 26, 2025. Severity: Critical. Recall number: D-0230-2025.