The company initiated the recall of the blood pressure treatment after a pharmacy reported observing foreign particles in a vial. The presence of these particles in the injectable solution can lead to local irritation or swelling, according to a Jan. 24 news release from the FDA.
In addition, if the particles enter the bloodstream, they could block blood vessels, potentially causing complications such as stroke or death.
Phenylephrine hydrochloride injection is commonly used in patients undergoing anesthesia. Provepharm has said no adverse events have been linked to the recall.
Healthcare providers and distributors are being urged to immediately cease use of the affected lot and return the product.
