Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Sub-potent Drug
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.
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 CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Reason Lack of Assurance of Sterility
Reason CGMP Deviations
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