HIGH

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...

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Quick Facts at a Glance

Recall Date
May 1, 2026
Hazard Level
HIGH
Brands
PRIMIDONE, American Health Packaging
Geographic Scope
1 states

Hazard Information

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter

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Full Description

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. Generic: PRIMIDONE; Brand: PRIMIDONE. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.. Classification: Class III. Quantity: 225,000 tablets. Distribution: USA Nationwide

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot 1028739
exp 12/31/2027
Lot 1025622
exp 06/30/2027
UPC Codes
68084-202
68084-203
68084-203-11
+3 more
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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