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FDA Recalls Polymyxin B, Vecuronium Bromide Vials Due to Glass Particulate Matter


The FDA initiated a voluntary recall of polymyxin B for injection USP and vecuronium bromide for injection after visible glass particles were discovered in a limited number of vials. The recall is still ongoing and the manufacturer of both products issued “updated guidance” through the FDA, urging health care facilities to examine their stocks of both solutions to remove any vials from the affected lots. The FDA's enforcement report also warned of glass particles in a lot of 20% acetylcysteine solution.

 

According to the enforcement report, particulate matter in injections “may cause adverse events after intravenous administration, including vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of capillaries and arteries, anaphylactic shock, and death.” Intrathecal administration into the cerebrospinal fluid “may serve as a nidus for the development of chemical meningitis.” Administration to the eye—a particular concern for polymyxin B, which is used topically and subconjunctivally to treat some eye infections—“can cause corneal abrasion/laceration, lacrimal tear and general irritation.”

 

Polymyxin B is an antibiotic indicated in the treatment of acute infections caused by susceptible strains of Pseudomonas aeruginosa.

 

Vecuronium Bromide is a muscle relaxant indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

 

See the FDA enforcement report.

 

 

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