Ascent Pharmaceuticals is recalling approximately 45,875 bottles of Oxycodone Hydrochloride (15 mg) tablets because the product labels are missing the required 'CII' symbol for federally controlled substances. This prescription pain medication was manufactured for Camber Pharmaceuticals and distributed nationwide in 100-count bottles. Consumers who have these bottles should be aware that the labeling error may lead to the medication being handled or stored without the strict oversight required for Schedule II controlled substances.
The missing 'CII' symbol means the product is not properly identified as a high-potential abuse drug, which could result in improper handling, storage, or tracking of the medication. While the medication itself is not defective, the labeling failure violates federal safety regulations designed to prevent the misuse of controlled substances.
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Sources: FDA iRES · Raw API Response
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