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news.Cumberland Pharmaceuticals has initiated a recall of six lots of Acetadote (acetylcysteine) injection in the US, as some of them were found to have particulate matter from the glass vial.
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Cumberland has informed the US Food and Drug Administration (FDA) of its plan to voluntarily recall these lots of Acetadote as a precautionary measure.
According to the company, the recall is not being initiated as a result of any known adverse medical events and it affects a limited supply of product.
The product which is being recalled is Acetadote (acetylcysteine) Injection, 20% solution (200mg/ml) in 30ml single dose glass vials, which was distributed to US wholesalers and distributors nationwide.
The company’s Acetadote injection is indicated to prevent or lessen liver injury following the ingestion of potentially toxic quantity of acetaminophen.