The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-release Capsules (28mg), a medication used to treat symptoms of Alzheimer's disease. This voluntary recall was initiated because the drug failed dissolution testing during stability studies, showing high results that were outside of the required specifications. These capsules are packaged in 100-count unit dose cartons under the Major Pharmaceuticals brand (NDC 0904-6735-61) and were distributed nationwide across the United States.
The drug failed dissolution testing, which means the medication may release its active ingredient at a different rate than intended. This could potentially lead to inconsistent blood levels of the medication, affecting how well the drug treats the patient's symptoms or increasing the risk of side effects.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
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.