← FDA ENFORCEMENT
D-0230-2025Class I

Provepharm Inc.

Recalling firm
Provepharm Inc.
Product type
Drug
Status
Ongoing
Report date
2025-02-26
Distribution
Nationwide in the U.S.
Firm state
PA
Product quantity
24640 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter.

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.