PAR Sterile Products LLC is recalling four lots of Buprenorphine HCl Injection (0.3mg/mL) because white, crystalline particles were discovered in some vials during an inspection. This prescription medication is an injectable pain reliever supplied in packages of five 1mL single-dose vials. The presence of these particles in the solution means the product is not sterile and could cause serious health complications if administered. No incidents or injuries have been reported to date.
Injecting a solution containing crystals or solid particles can block blood vessels, leading to inflammation, blood clots, or damage to vital organs. There is also a risk of severe allergic reactions or infection at the injection site.
Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977
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 · Raw API Response
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