Mylan Pharmaceuticals Inc. is voluntarily recalling 1,414 bottles of bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg. The recall was initiated because routine stability testing revealed that the medication did not meet the required specifications for impurities and degradation compounds. This medication is a prescription drug typically used to treat depression and seasonal affective disorder.
The presence of impurities or degradation products exceeding specified limits can reduce the effectiveness of the medication or potentially cause unexpected side effects, although the risk level for this specific recall is categorized as low.
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Sources: FDA iRES · Raw API Response
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