Drug 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

D-0585-2026

June 03, 2026

Class III

Product summary

Firm: Amneal Pharmaceuticals, LLC
Event: Event 99146
Status: Ongoing
Classification: Class III
Quantity: 27,936 100-count bottles
Official record key: drug-enforcement:D-0585-2026

Official wording

Reason: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Code information: Lot AM251676, EXP 11/31/2028

Distribution pattern: Nationwide within the USA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.