An urgent recall has been issued for a blood pressure drug for being contaminated with a potentially fatal substance.
Pennsylvania-based pharmaceutical firm Provepharm Inc is voluntarily recalling vials of phenylephrine hydrochloride, which is used by surgeons to treat hypotension (low blood pressure) that may occur during surgery.
Over 51 million people in the US have surgery each year and the Cleveland Clinic notes that phenylephrine is ‘often used’ to ‘treat very low blood pressure or serious heart problems such as irregular heartbeat’.
The recall was actioned after a customer reported seeing a ‘visible black particulate matter’ in a single-sealed vial of the colorless solution.
The company warns that injecting the compromised drug could cause ‘irritation or swelling’ and in severe cases, death.
It explains: ‘If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death.’
The medication was distributed nationwide in the US to wholesalers.
It is designed for injection or infusion into a vein, or injection into a muscle or under the skin.
Pennsylvania-based pharmaceutical firm Provepharm Inc is voluntarily recalling vials of phenylephrine hydrochloride
It is only given by health care professionals in a hospital or clinic setting.
To date, Provepharm Inc. has not received any reports of adverse events or injuries associated with the recall.
The recalled product, packaged in single dose 10ml vials, can be identified from its lot code, ‘24020027,’ and expiry date, December 2025.
It also has the national drug code (NDC) ‘81284-213-01.’
Provepharm Inc says it has notified all of its distributors and customers and coordinating the return of all recalled products.
Anyone in procession of the recalled vials have been instructed to stop using it immediately and return the product.
Meanwhile, consumers have been advised to contact a healthcare provider if they have experienced any problems that may be related to the drug product.
The Mayo Clinic says other side effects of the medication that are cause for concern include breathing problems, chest pain, unusual sweating, an irregular heartbeat and feeling faint or lightheaded.
