Pharmaceutical manufacturer American Regent has recalled three lots of Epinephrine Injection, according to a press release from the FDA on Thursday. Consumers reportedly complained about “leaking and cracked vials,” which led the company to investigate and find particulate matter such as nylon, cellulosic, acrylic, polyethylene, and glass.
“Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death,” according to the press release.
“Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. Additionally, cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients.”
The company reports that it hasn’t had any reports of adverse health outcomes from the potentially contaminated product yet.
EpiPens, the consumer product containing epinephrine in pre-measured doses with an auto-injector, are not included in this recall. The recalled vials are made to allow the person administering the shots to choose how much epinephrine to draw from a vial to treat a patient who’s experiencing an allergic reaction.
The recalled product is Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) packaged in multi-dose vials, according to the FDA notice, with an NDC number of 0517-3030-01 and lot numbers: 25128L1C0, 25280L1C0, and 26108L1C0.
American Regent is reportedly notifying distributors and customers by letter and organizing the return of the vials. Customers who may have the product are told not to use it and to return it to their place of purchase or destroy it.
The product is just the latest example of U.S. products found to contain foreign substances in recent months, including popsicles with glass, Pillsbury rolls with glass, plant-based chicken nuggets with plastic, sourdough bread with metal, as well as baked spaghetti and chicken cobbler meals with metal slivers. And that’s to say nothing of all the other food recalls we’ve been plagued with recently under President Trump.
Anyone with questions about the Epinephrine Injection recall is encouraged to contact the company by phone at 800-645-1706 from 8 a.m. to 6 p.m. ET, Monday through Thursday, or 8 a.m. to 4 p.m. ET on Fridays.
American Regent didn’t immediately respond to questions emailed on Friday. Gizmodo will update this article when we hear back.
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