
The recent recall of Provepharm’s phenylephrine hydrochloride injection has sparked immediate concerns following an FDA warning about contamination risks.
Key Takeaways
- Provepharm Inc. recalls a specific lot due to visible black particulate matter contamination.
- The recall affects lot number 24020027 with an expiry date of December 2025.
- Customers are advised to stop using and return the affected vials to Sedgwick.
- Phenylephrine Hydrochloride Injection is used to manage hypotension post-anesthesia.
- No adverse health events have been reported related to the recall.
Contamination Sparks Immediate Recall
Provepharm Inc. has voluntarily recalled specific lot number 24020027, with an expiry date of December 2025, of phenylephrine hydrochloride injection following the discovery of black particulate matter in the vials. This injectable drug is typically administered to manage hypotension after anesthesia. The FDA emphasized the severe health risks posed by possible contamination, including the potential for obstructed blood vessels leading to strokes or fatalities. Despite no reported injuries, immediate discontinuation and return of the vials are strongly advised for safety.
Provepharm is working with Sedgwick as the recall provider to address any queries and manage the return process of the affected products. Customers seeking more information can reach out to Provepharm directly, ensuring a swift response to prevent any health hazards. The FDA’s swift response underscores their commitment to safeguarding public health against potential medicinal adversities.
Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug https://t.co/7MnMWlvUXf pic.twitter.com/Y1vJsIWSB6
— U.S. FDA Recalls (@FDArecalls) January 9, 2024
Detailed Steps for Customers
A customer complaint from a pharmacy triggered this recall after visible black particulate matter was found in a single-sealed vial. The FDA has advised customers who have purchased the affected lot to immediately suspend usage. The vials should be returned to Sedgwick, the authorized recall handler, for proper disposal. Provepharm encourages any customers needing further details to engage with them directly.
Customers should promptly return the product to address any potential risks and ensure compliance with the recall procedure. Provepharm is committed to resolving this matter diligently to maintain health safety standards. Additionally, inquiries about this recall can be directed to Sedgwick or Provepharm for further guidance.
Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug https://t.co/7MnMWlvUXf pic.twitter.com/Y1vJsIWSB6
— U.S. FDA Recalls (@FDArecalls) January 9, 2024
Other Current Recalls and Safety Concerns
The recall of phenylephrine hydrochloride is one among other significant product recalls currently in effect. Notably, Sagent Pharmaceuticals, Inc. has also announced a recall of three lots of the same injection due to issues with crimped vial overseals that could lead to non-sterile products. In addition, popular products like Ford vehicles, space heaters, and pancake mixes are also under recall for other safety concerns.
Per an announcement from the FDA: “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.”
Consumers impacted by any of these recalls should stay informed and follow the procedures set by respective manufacturers to avoid risks. It remains critical for manufacturers to ensure product safety and maintain trust. FDA encourages reporting any adverse reactions to their MedWatch Adverse Event Reporting program to manage public health concerns efficiently.
Sources:
- https://www.usatoday.com/recalls/food-and-drug/FDA-kS8Wc86ofFo/
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-phenylephrine-hydrochloride-injection
- https://www.newsweek.com/blood-pressure-drug-recall-phenylephrine-hydrochloride-provepharm-2021171