Published recall report · Labelling errorUpdated · 4 months ago
Amerisource Health Services LLC recall: 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
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
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
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
- Producer
- Amerisource Health Services LLC
- Brand
- PRIMIDONE
1028739
- Dates on pack
- Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
1025622
- Dates on pack
- Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
More detail
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
In the news
Reporting from news publishers. Follow the official notice for product advice.
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