Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Inco
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
About Medications recalls
Drug recalls in the United States are overseen by the FDA's Center for Drug Evaluation and Research. They may be initiated voluntarily by the manufacturer or requested by the FDA when contamination, potency issues, or labeling errors are identified. Class I drug recalls — the most serious — involve situations where the product may cause serious injury or death. Before stopping a prescription medication due to a recall, contact your pharmacist or prescriber: for many medications, abrupt discontinuation carries its own risks. Your pharmacy can usually arrange an emergency replacement from an unaffected lot or an alternative manufacturer at no additional cost.
What to do if you're affected
- →Stop taking the medication if it matches the recalled lot number.
- →Contact your doctor or pharmacist before stopping any prescription.
- →Return the product to your pharmacy for a refund or replacement.
- →Call the manufacturer's hotline listed on the official recall notice.
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.
Opens the official government source. Always refer to official sources for the most current information.