FDA Warns – Provepharm Inc. recalls 1 lot of Phenylephrine hydrochloride Injection (USP, 10 mg/ mL) after black particulate found in vial

According to the FDA, the pharmaceutical company Provepharm Inc. out of Pennsylvania is recalling one lot of their Phenylephrine hydrochloride Injection (USP, 10 mg/ mL).  The company says the pre-filled vials may be contaminated with an unknown particulate.

Provepharm Inc. announced the recall at the hospital/facility level on Friday, January 24th, clarifying that it applies to the Pharmacy Bulk Package of the Phenylephrine hydrochloride Injection (USP, 10 mg/ mL). The National Drug Code for the recalled medication is 81284-213-01 with a lot number of 24020027 and an expiration date of December 2025. Health care providers and medical facilities can locate the NDC and lot number on both the box and on the label for the vial itself. The medication was distributed to health care facilities throughout the United States.

Phenylephrine hydrochloride Injection is indicated for treatment of low blood pressure, or hypotension, caused by vasodilation in surgery. It is often administered by anesthesiologists during surgical procedures.

Thus far, Provepharm Inc. has not received any reports of injury linked to the recalled drug. The company initiated the recall after receiving a complaint from a pharmacy regarding an unidentifiable black particulate in one of the vials. Particulate in an injectable drug can cause skin reactions at the site of injection. In more serious instances, particulate matter can enter the blood vessels of patients and create blockages to “blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death.”

Provepharm Inc. has notified all customers of the recall. They ask that customers and distributors return any recalled Phenylephrine hydrochloride Injections from lot number 24020027 to Sedgwick , Event## 8664, 2670 Executive Drive Suite A , Indianapolis, IN 46241.

Anyone with questions or concerns about the recall can contact Sedgwick at 866-737-5394 or by email at provepharm8664@sedgwick.com.

Patients and health care providers can report any new adverse health events related to Provepharm’s Phenylephrine hydrochloride Injection (USP, 10 mg/ mL) through the FDA’s MedWatch Online Voluntary Reporting Form.

 

If you or a loved one has suffered an injury or adverse health outcome after receiving an injection of a contaminated medication, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medication to health care facilities in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.