Johnson Matthey Inc. has recalled one 416.95-gram glass container of Remifentanil HCl active pharmaceutical ingredient (API) because testing revealed an unknown impurity that exceeded safety specifications. This specific batch of raw medicinal ingredient was distributed to a manufacturer in West Virginia who may have used it to produce finished prescription medications sold nationwide. Since this is a raw ingredient for pharmaceutical manufacturing, consumers who use Remifentanil products should be aware of this potential quality issue in the supply chain.
The presence of an unknown impurity above the allowed limits means the medication may not meet safety and purity standards, potentially leading to unexpected side effects or reduced effectiveness for patients.
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Sources: FDA iRES · Raw API Response
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