Amerisource Health Services LLC — Class III: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only
Amerisource Health Services LLC has initiated a Class III recall for Primidone Tablets USP (50 mg) due to trace amounts of Acemetacin API cross-contamination within the drug's active pharmaceutical ingredient.
This recall affects Amerisource Health Services LLC, American Health Packaging, and healthcare facilities or pharmacies utilizing unit-dose blister packs of 50 mg Primidone tablets.
A Class III recall indicates that use of or exposure to the product is not likely to cause adverse health consequences. However, the presence of trace API contamination suggests a potential failure in cleaning validation or supplier quality management at the API manufacturing level, which may require an investigation into the robustness of the manufacturer's contamination control strategy.
QA teams should verify if any batches of Primidone (NDC 68084-202-01) remain in inventory; Regulatory and Supply Chain departments should monitor for potential supply disruptions if this API contamination affects multiple lots or alternative repackagers.
Class III. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.. Product: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11. Firm: Amerisource Health Services LLC (Columbus OH United States). Status: Ongoing.
Open in openFDA / FDA.gov