Par Pharmaceutical is recalling approximately 16,207 bottles of Pramipexole dihydrochloride extended release tablets (0.75 mg), a prescription medication used to treat Parkinson's disease and Restless Legs Syndrome. The recall was initiated because testing discovered that the finished product contains a known chemical impurity at levels exceeding current safety specifications. This voluntary recall affects 30-count bottles across several lot numbers distributed nationwide.
The medication contains degradation impurities that have exceeded approved safety levels. Consuming a drug with higher-than-allowed impurity levels could potentially lead to unexpected side effects or reduced effectiveness of the treatment over time.
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Sources: FDA iRES · Raw API Response
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