Elevated risk U.S. Food and Drug Administration

Provepharm Phenylephrine hydrochloride Injection, USP, 10 mg/ mL recall: Device & Drug Safety – Potential Foreign Material

Recall published 1+ years ago

Device & Drug Safety – Potential Foreign Material

Provepharm Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — foreign objects

Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

What the notice says: Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
January 24, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Provepharm
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Phenylephrine hydrochloride Injection, USP, 10 mg/ mL

What the company announced

FOR IMMEDIATE RELEASE – January 24, 2025 – Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product.

Risk Statement:

Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death. To date, Provepharm Inc. has not received any reports of adverse events or injuries associated with this recall.

Phenylephrine hydrochloride Injection is used for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia and is packaged in 10 mL vial, 1 single dose vial, with NDC code as 81284-213-01.

The product can be identified by product name on carton and vial label and with lot number 24020027 and Exp. Date: Dec 2025 (NDC 81284-213-01) (See enclosed vial label).

Phenylephrine hydrochloride Injection, USP, 10 mg/ mL, was distributed nationwide in the United States to wholesalers.

Provepharm Inc., in collaboration with its recall provider, Sedgwick, is notifying distributors and customers via UPS Ground and coordinating the return of all recalled products.

Wholesalers, distributors, compounding companies and hospitals in procession of the recalled Phenylephrine hydrochloride Injection, USP, 10 mg/ mL lot number 24020027, Exp date December 2025, should immediately cease use of and return the product to Sedgwick at the following address

Sedgwick

Event## 8664

2670 Executive Drive, Suite A

Indianapolis, IN 46241

Customers with questions regarding this recall can contact from 8:00 am to 5:00 pm (EST) Monday - Friday at:

Product Returns:

Contact Sedgwick at:

IVR: 866-737-5394

FAX: 866-250-4503

Email: [email protected]

Medical-related Questions Contact Medical Information at:

1-833-727-6556

Email: [email protected]

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24020027
  • 10

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • December 2025
  • Dec 2025

NDC number

On the carton and again on the bottle or blister label.

  • 81284-213-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 mg
  • 10 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Foreign material

Provepharm — Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  3. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  4. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: Wholesalers, distributors, compounding companies and hospitals in procession of the recalled Phenylephrine hydrochloride Injection, USP, 10 mg/ mL lot number 24020027, Exp date December 2025, should immediately cease use of and return the product to Sedgwick at the following address

Company contact: Provepharm Inc. — Consumers: Sedgwick, 866-737-5394, [email protected] — Media: Provepharm Inc., 610-601-8600

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Provepharm prescription & otc drugs recalled?

Device & Drug Safety – Potential Foreign Material Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 24020027, 10; best-by date December 2025 or Dec 2025. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

The notice says: Wholesalers, distributors, compounding companies and hospitals in procession of the recalled Phenylephrine hydrochloride Injection, USP, 10 mg/ mL lot number 24020027, Exp date December 2025, should immediately cease use of and return the product to Sedgwick at the following address

Where was the recalled product sold?

It was distributed nationwide.

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