Flavine North America Inc. is recalling approximately 5,300 kg (about 11,684 pounds) of Praziquantel USP, an active pharmaceutical ingredient used in veterinary medicine. An FDA inspection revealed that the manufacturer failed to follow required record-keeping practices and factory standard operating procedures (SOPs). These violations of Current Good Manufacturing Practices (cGMP) mean the quality and safety of the product cannot be guaranteed, potentially making it adulterated. The affected product was distributed to pharmaceutical manufacturers in Missouri and Iowa.
Failure to follow standard manufacturing and record-keeping protocols can lead to the production of medicine that is contaminated, lacks the correct potency, or is otherwise unsafe for animal use. While no specific injuries have been reported, the lack of oversight during production means the final product may not meet safety standards.
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 · Raw API Response