Amerisource Health Services LLC recalls Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American He…
- Recall date
- May 1, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0537-2026
- FDA classification
- Class III
- Brand / firm
- Amerisource Health Services LLC
- Sold / distributed
- USA Nationwide
Why it was recalled
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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