Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
CGMP Deviations: not manufactured according to current good manufacturing practices.
BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
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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