Amerisource Health Services LLC: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Colum
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Amerisource Health Services LLC
- 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
- Reason / hazard
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- USA Nationwide
- Recall initiated
- 2026-05-01
- Code info
- Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- Product quantity
- 225,000 tablets
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Columbus
- State
- OH
- Country
- United States
- Event id
- 98884
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