Teva Pharmaceuticals USA, Inc. is recalling 10,672 30-count bottles of Actavis Budesonide Extended-Release Tablets (9mg) due to a failure to meet dissolution specifications. This medication, used to treat conditions like Crohn's disease, was found during testing to not break down at the required rate, which could impact how the drug is absorbed into the body. The recall affects bottles with NDC 0591-2510-30, Lot # 100047273, and an expiration date of July 2025.
The failure to meet dissolution specifications means the tablets may not release the medication at the intended speed or location in the digestive tract. This could potentially reduce the effectiveness of the treatment or lead to unexpected side effects, although no injuries have been reported to date.
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Manufactured by Actavis Laboratories FL, Inc. and distributed by Actavis Pharma, Inc. (Teva Pharmaceuticals USA, Inc.).
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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