Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Particulate Matter: Hair was found in products
Reason Presence of Particulate Matter: Hair was found in products
Reason Presence of Particulate Matter: Hair was found in products
Reason Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Reason Lack of Assurance of Sterility
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