Pfizer's Hospira recalls anesthetic after finding 'visible' particulate during annual inspection

Hospira, a subsidiary of Pfizer, issued a voluntary recall for one lot of the anesthetic propofol after discovering “a visible particulate” in a vial during an annual inspection.

Propofol is generally used to induce and maintain anesthesia and sedation for patients undergoing surgery. The lot of 100-ml, single-patient use, glass flip-top vials being recalled is DX9067 with an expiration date of May 1, 2023.

The product was distributed nationwide in the U.S. to wholesalers, hospitals and the Department of Defense between June 10, 2020, and June 26, 2020, according to the recall letter posted on the FDA website.

The risks to patients due to the contamination include blockage of blood vessels that could lead to decreased blood flow to the brain, heart attack, pulmonary embolism and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur, the company said.

Hospira hasn’t received any reports of adverse effects related to the recall.

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Pfizer's Hospira recalls hospital anesthetics, flags 'moderate to high severity' safety risks

Recalls of sterile injectables aren’t new to Hospira, which Pfizer purchased in 2015. In May 2021, Hospira issued a recall of one lot of injectable hospital anesthetics bupivacaine hydrochloride (HCL) and lidocaine HCL after an investigation into a customer report revealed a portion of each lot was mislabeled as the other product.