Phenylephrine hydrochloride Injection, USP, 10 mg/ mL

  • Device & Drug Safety – Potential Foreign Material
  • Company: Provepharm Inc.
  • Drugs
  • FDA
  • January 24, 2025

Product details

  • Phenylephrine hydrochloride Injection, USP, 10 mg/ mL

Company announcement

Provepharm Inc. is recalling one lot of Phenylephrine hydrochloride Injection due to the presence of visible black particulate matter.

The affected product was distributed nationwide to wholesalers.

No adverse events or injuries have been reported as of January 24, 2025.

Risk:

Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. 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.

Impacted states: Nationwide

Products:

- Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package)

Contact

For more information, call 866-737-5394 or email provepharm8664@sedgwick.com.

View the original FDA notice

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