Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single uni
Summary
The FDA issued a Class I for Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmac by Provepharm Inc.. Reason: Presence of Particulate Matter..
Details
Source
Drug Recall
External ID
D-0230-2025
Action Date
2025-02-26
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot# 24020027, Exp Date: 12/31/2025
Quantity Affected: 24640 vials
Reason for Recall
Presence of Particulate Matter.
Distribution
Nationwide in the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-21
Company
Collegeville, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 53 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Provepharm Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Provepharm Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Provepharm Inc. have FDA actions?
Provepharm Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0230-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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