Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Provepharm Inc. has announced a voluntary recall of a specific lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) due to the presence of foreign particulate matter in a single-sealed vial. The affected lot, number 24020027, has an expiry date of December 2025.
The recall follows a customer complaint from a pharmacy that reported finding visible black particulate matter in a vial of the product. Phenylephrine hydrochloride Injection is commonly used to treat hypotension (low blood pressure) in the setting of anesthesia.
Risk of Serious Health Complications
The presence of foreign material in injectable products can pose serious health risks. Administration of the affected lot could lead to local irritation or swelling at the injection site. More dangerously, if particulate matter enters the bloodstream, it may travel to critical organs, potentially blocking blood vessels in the heart, lungs, or brain. This can result in severe complications, including stroke or even death.
As of the recall announcement, Provepharm Inc. has reported no adverse events or injuries linked to this issue. However, the company is acting out of caution and has initiated the recall in collaboration with recall provider Sedgwick.
The recalled product was distributed nationwide to wholesalers, and is packaged in 10 mL vials with a single dose per vial. The affected lot can be identified by the following details:
- Lot number: 24020027
- Expiry Date: December 2025
- NDC code: 81284-213-01
Customers are advised to carefully check their inventory and immediately cease use of the product from this specific lot. The affected vials are labeled with the product name and expiration date for easy identification.
Action for Affected Parties
Provepharm is notifying distributors, wholesalers, compounding companies, and hospitals nationwide about the recall. These parties should immediately return any remaining stock from the affected lot to Sedgwick using the following address:
Sedgwick
Event 8664
2670 Executive Drive, Suite A
Indianapolis, IN 46241
For product returns, customers can contact Sedgwick at:
- IVR: 866-737-5394
- FAX: 866-250-4503
- Email: provepharm8664@sedgwick.com
For medical-related questions, customers should contact Provepharm’s Medical Information at:
- Phone: 1-833-727-6556
- Email: safety-us@provepharm.com
Consumers and Healthcare Providers Advised to Monitor
Consumers who have received the recalled product and experienced any adverse effects should contact their physician or healthcare provider immediately. Any related issues or adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting program.
The recall is being conducted with the knowledge and oversight of the U.S. Food and Drug Administration (FDA). Provepharm is committed to ensuring the safety and quality of its products and is actively working to facilitate the return of affected vials.
For further information, customers are encouraged to reach out to the provided contact points during business hours (8:00 am to 5:00 pm EST, Monday through Friday).
