FDA Recalls Common Blood Pressure Medication Over Contamination Concerns
Contaminants in a popular blood pressure drug have sparked an urgent FDA recall—get the details
Medicine may not be an exact science, but precision is crucial for patient care. That’s why the presence of unknown particles in injectable vials of Phenylephrine Hydrochloride prompted a recall by the U.S. Food and Drug Administration (FDA) last week. Read more about the details of this drug recall and how you can protect your health.
FDA warns of contamination risks in blood pressure medication
Last Friday, Provepharm Inc. initiated a recall of the blood pressure drug Phenylephrine Hydrochloride Injection after several vials were found to contain small foreign particles.
Woman's World Answers
“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,” reads the FDA’s statement reason the recall.
The FDA warns that injecting the product containing “visible black particulate” could cause irritation or swelling, and if the particles enter the bloodstream, they may block blood vessels in the heart, lungs, or brain, leading to serious complications like stroke or death.
The affected batch is identified by lot number 24020027 with an expiry date of December 2025 on the product’s carton.
The Pennsylvania-based independent, international specialty pharmaceutical company, Provepharm, has yet to receive any reports of adverse events or injuries associated with the recall.
What to know about the recalled blood pressure drug
Phenylephrine hydrochloride injection is used to manage and treat clinical hypotension, also known as low blood pressure.
Low blood pressure is dangerous and often an indication that your vital organs are not receiving enough oxygen to function properly.
Chronic low blood pressure can lead to hazardous health conditions including fainting spells, organ damage, heart problems and reduced brain functioning.
Phenylephrine hydrochloride is often used after surgery to counteract the dilation of blood vessels—a common cause of hypotension—caused by anesthesia.
Next steps in the blood pressure drug recall
Phenylephrine hydrochloride is a medicine that should be administered by or under the direct supervision of your doctor. Therefore, it is unlikely that patients will have to worry about taking action according to the drug’s recall.
The FDA advises wholesalers, distributors, compounding companies, and hospitals with the recalled Phenylephrine Hydrochloride Injection to immediately stop using the product and return it to Sedgwick, Provepharm’s recall provider.
Currently, Sedgwick and Provepharm are working together with the drug’s distributors and customers via UPS Ground shipping to coordinate the return of the recalled phenylephrine hydrochloride injection.
If customers have questions about the recall or believe they are experiencing any complications related to the recall, the organization urges them to call 1-833-727-6556 or email safety-us@provepharm.com.
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