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Amneal Pharmaceuticals, LLC: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, A

DrugsSource: FDA (drug) · Date: 2026-06-17

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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
Amneal Pharmaceuticals, LLC
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
Status
Ongoing
Distribution / sold at
Nationwide within the USA.
Recall initiated
2026-06-03
Code info
Lot AM251676, EXP 11/31/2028
Product quantity
27,936 100-count bottles
Voluntary mandated
Voluntary: Firm initiated
City
Bridgewater
State
NJ
Country
United States
Event id
99146
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