Provepharm Inc. has announced a recall of phenylephrine hydrochloride injection due to contamination risks following customer discovery of black particulates.
Quick Takes
- Provepharm Inc. recalls a specific lot due to visible black particles in the injection.
- The recall affects lot number 24020027, with an expiry date of December 2025.
- Recalled due to a customer complaint from a pharmacy.
- No injuries reported; usage should be stopped, and products returned.
Reason for Recall
Provepharm Inc. has initiated a voluntary recall of a specific lot of its phenylephrine hydrochloride injection. The recall affects lot number “24020027,” which was set to expire in December 2025. The recall was prompted by a customer complaint from a pharmacy, which detected visible black particulate matter in a vial. This contamination poses a severe safety hazard, as particulates in injectables can obstruct blood flow, potentially leading to serious health consequences such as strokes or even death.
Phenylephrine hydrochloride injection, primarily used to manage low blood pressure during anesthesia, is critical in maintaining vital functions post-surgery. The discovery of contaminants in this product raises significant concerns over its safety and efficacy. The recall is a precautionary measure to prevent potential adverse effects on patients receiving this medication.
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
Customer Guidance and Actions
Provepharm advises all users of the affected lot to cease its use immediately and return it through Sedgwick, their appointed recall partner. The company has assured that they are reachable for any related queries to ensure the safety and professionalism in handling healthcare products. As of now, no related injuries or adverse effects have been reported, yet it remains imperative that affected parties follow the recall instructions diligently.
For medical professionals and individuals with related concerns, contacting Provepharm for medical inquiries or Sedgwick for questions regarding the recall process is recommended. Further information on the recall and contact references can be found through official channels provided by Provepharm.
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
Implications and Preventive Measures
The recall underscores the critical importance of stringent quality controls in pharmaceutical manufacturing processes. Contaminants in medical products can have devastating effects, emphasizing the vigilance required in monitoring production lines. Healthcare providers are advised to stay informed about recalls to ensure they do not inadvertently administer compromised products.
Ensuring that recalled products are not used within medical practices is essential. Customers and healthcare providers should report any product-related issues to the FDA’s MedWatch program, facilitating monitoring and preventing future incidents. Though rare, such events reinforce the ongoing need for regulatory bodies to maintain high safety standards in drug and medical product manufacturing.
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