Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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