Macleods Pharma USA, Inc. is voluntarily recalling 1,837 bottles of Pramipexole Dihydrochloride Tablets (0.125 mg), a prescription medication used to treat Parkinson's disease and Restless Legs Syndrome. This recall was initiated because a stability study found the drug to be subpotent, meaning it does not contain the full required amount of the active ingredient. Patients using subpotent medication may not receive the intended therapeutic dose, which could lead to a return or worsening of their symptoms. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lot.
The tablets tested 'out of specification' for potency during routine stability testing, which means the medication may not be strong enough to effectively treat the patient's condition. While no injuries have been reported, subpotent doses of this medication can lead to inadequate control of movement disorders or sleep-related symptoms.
Drug recall baseline remedy
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.