Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American He
Summary
The FDA issued a Class III for Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per cart by Amerisource Health Services LLC. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API..
Details
Source
Drug Recall
External ID
D-0536-2026
Action Date
2026-05-27
Status
Ongoing
Category
drug
Product Description
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Lot/Code Info: Lot#: 1027583, Exp 09/30/2027
Quantity Affected: 63,500 tablets
Reason for Recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-01
Company
Columbus, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amerisource Health Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amerisource Health Services LLC have FDA actions?
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0536-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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