Amerisource Health Services Llc: Primidone Tablets, Usp, 250 Mg, 100 Tablets (10 X 10 Unit Dose Blister) Per Carton
Recall Summary Amerisource Health Services is recalling Primidone Tablets (250 mg) distributed nationwide because the medication was contaminated with trace amounts of Acemetacin, a different drug, during manufacturing. The affected product is in 100-tablet cartons with specific NDC numbers (68084-203-01 and 68084-203-11). This recall affects patients who received this prescription medication across all U.S. states and Washington, D.C.
- Recalling firm
- Amerisource Health Services LLC
- Product
- 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
- Reason
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-01
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/e2629690-d00f-47b8-9003-1d3928b98e67