Jubilant Cadista Pharmaceuticals is recalling 5,760 bottles of BuPROPion Hydrochloride Extended-Release (XL) 150 mg tablets. This recall was initiated because the medication failed to meet dissolution specifications during a nine-month stability check. This defect means the drug may not release properly into the body, which could affect how well the medication works for patients.
The medication failed to dissolve at the required rate, which may lead to the drug being released too slowly or inconsistently. This can result in the patient receiving an sub-therapeutic dose, potentially failing to manage the condition for which it was prescribed.
Pharmaceutical product refund/exchange
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Sources: FDA iRES · Raw API Response
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