SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Defective container: Ineffective seal between the cap and jar of the affected product.
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022
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 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Reason cGMP deviations: Temperature abuse
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.