Recall
FDAHealthJanuary 21, 2025

Provepharm Inc. — 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

⚠️ Presence of Particulate Matter.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
January 21, 2025

Nationwide in the U.S.

What's affected?

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
Lot code
24020027

Additional details

Lot# 24020027, Exp Date: 12/31/2025

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 24640 vials.

View original FDA notice →

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