Provepharm recalls Phenylephrine injection due to risk of particulate contamination

Provepharm Inc. is conducting a voluntary nationwide recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package), lot number 24020027, with an expiration date of December 2025. The recall was initiated after a black particulate was discovered in a vial.

Details

• Product: Phenylephrine Hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package)

• Lot Number: 24020027

• Expiration Date: December 2025

• NDC: 81284-213-01

• Distribution: Shipped nationwide to healthcare facilities in the United States

Impact

Injection of particulate matter can lead to:

• Local reactions at the injection site

• Blood vessel blockages in organs such as the heart, lungs, or brain

• Possible life-threatening complications including stroke

Remedy

• Stop using any vials from the affected lot.

• Return all recalled medication to:
  Sedgwick, Event# 8664
  2670 Executive Drive Suite A
  Indianapolis, IN 46241

• Direct questions or concerns to Sedgwick at 866-737-5394 or email provepharm8664@sedgwick.com.

• Report any adverse events to the FDA’s MedWatch Online Voluntary Reporting Form.

Sources

• FDA Drug Recalls

• PAHO Notice on Particulate Matter Recall

• DrugOffice.gov.hk Announcement

• TruLaw Advisory