LGM Pharma LLC has initiated a voluntary recall of Ronidazole (NDC# 17369-301-01), an active pharmaceutical ingredient used for veterinary compounding. The recall is due to serious manufacturing deviations at the supplier facility, including production in a non-classified area without an HVAC system and the presence of out-of-specification residual solvents. This recall follows a downstream recall from the API supplier, Menadiona, SL, and affects several bulk sizes distributed in New Jersey and Arizona.
The lack of proper environmental controls and HVAC systems during manufacturing increases the risk of contamination or chemical impurities. Use of this raw material in veterinary medications could lead to unpredictable patient outcomes or adverse reactions in animals due to potential impurities or solvent levels.
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Manufactured by Menadiona, SL in Spain. For Veterinary Compounding Use Only. Rx Only.
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