Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, In
Manufacturer / Brand: Golden State Medical Supply Inc.
Reason for Recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Date Issued
Category
Medications
Status
voluntary
Issuing Agency
FDA CDER
About foreign material contamination
Foreign material contamination occurs when physical objects — such as metal fragments, glass shards, plastic pieces, bone chips, or other materials — are inadvertently introduced into a product during manufacturing or packaging. Ingesting foreign objects can cause cuts to the mouth, throat, or digestive tract; dental damage; choking; or internal injury. These recalls are typically issued after consumer complaints or internal quality checks identify the problem.
⚠ Inspect any remaining units of the product for visible foreign material before disposal, and report any injuries to the FDA at 1-800-FDA-1088.
What to do if you're affected
- →Check the lot number on your medication package against the specific lots listed in the recall notice — not every batch is always affected.
- →Do not stop a prescription medication without first consulting your doctor or pharmacist. Abrupt discontinuation of some drugs carries serious risks.
- →Contact your pharmacy — they can verify whether your dispensed lot is affected and arrange a replacement prescription.
- →For most insurance plans, a replacement fill triggered by a recall is covered even before the normal refill date.
- →Report any adverse effects to the FDA at 1-800-FDA-1088 or through MedWatch at fda.gov/safety/medwatch.
About the FDA CDER
This recall was issued by or conducted in cooperation with the FDA's Center for Drug Evaluation and Research (CDER), which oversees prescription and over-the-counter medications sold in the United States. Drug recalls may be initiated voluntarily by the manufacturer or at FDA's request after a quality problem is identified through manufacturer testing, FDA inspection, or adverse event reports. Recalls are classified by severity: Class I involves products that may cause serious injury or death; Class II and III involve lower levels of risk. Do not stop a prescription medication due to a recall without first consulting your doctor or pharmacist.
View all FDA CDER recalls →Opens the official government source. Always refer to official sources for the most current information.