Spectrum Laboratory Products is recalling several sizes of Ranitidine Hydrochloride (powder), USP, a prescription active pharmaceutical ingredient used in medications. The recall was initiated because testing detected the presence of N-Nitrosodimethylamine (NDMA), an impurity that is classified as a probable human carcinogen. This recall affects various container sizes ranging from 1 gram to 1 kilogram that were distributed to pharmacies for compounding.
The product contains NDMA, a substance that may increase the risk of cancer in humans if exposed to levels above acceptable limits over a long period of time.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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 ยท 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.