Provepharm Inc. has issued a voluntary recall of the Phenylephrine Hydrochloride Injections. The company said they’re pulling out the medication at hospital and institutional levels. The move was due to visible black matter in a sealed vial of the product.
The recall affects Lot# 24020027 (NDC# 81284-213-01) of Phenylephrine Hydrochloride Injection, USP. The 10 mg/ml medications have a December 2025 end date.
Phenylephrine Hydrochloride Injections were all sent to wholesalers and distributors. Compounding companies and hospitals also received the blood pressure medication.
Understanding the Issue
The injections are for treating hypotension. They’re often used in patients under anesthesia and headed to surgery.
The presence of a particulate matter is problematic. It can result in localized irritation or swelling. Foreign particles that enter the bloodstream could move to vital organs. They could block blood vessels and cause serious complications, like stroke. It could even be fatal.
Provepharm hasn’t received any reports of adverse effects related to this issue.
Next Steps to Take
Provepharm Inc. is set to notify distributors and customers via UPS Ground. The pharmaceutical company is working with recall provider Sedgwick. Both are working to have the blood pressure injection returned.
Entities and organizations in possession of Phenylephrine Hydrochloride Injection should stop using it. They should return the recalled product to:
Sedgwick
- Event #8664
- 2670 Executive Drive, Suite A
- Indianapolis, IN 46241
Affected parties can also contact the company at:
- IVR: 866-737-5394
- Fax: 866-250-4503
They can also send an email to provepharm8664@sedgwick.com.
Those with medical-related inquiries can call 1-833-727-6556 or email safety-us@provepharm.com.
Provepharm says consumers should consult their physician if they’re experiencing issues.