AuroMedics Pharma LLC is recalling 35,520 vials of Polymyxin B (polymyxin B) for Injection USP because a hair and other particulate matter were discovered in a vial from one lot. This product is a prescription antibiotic used in hospitals for parenteral (injection) or ophthalmic (eye) administration. There have been no reported injuries related to this recall.
Injecting a drug containing foreign materials like hair can cause localized inflammation, infection, or more serious complications such as a life-threatening blockage in the blood vessels (embolism). Foreign particulates may also trigger systemic allergic reactions.
Distributed by AuroMedics Pharma LLC, E. Windsor, NJ 08520.
AUROMEDICS Polymyxin B for Injection USP, 500,000 Units per Vial, Rx only
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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