Amneal Pharmaceuticals, LLC: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. L…
| Source | FDA · Drugs |
|---|---|
| Date | 2026-06-17 |
| Product | Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 |
| Reason / hazard | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. |
| Classification | Class III |
| Official notice | — |
| Record ID | fda-drug:D-0585-2026 |