Class I · High risk Ongoing
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.
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
What was recalled
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
- Recalling firm
- Fabscout Entertainment, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1170-2014
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.
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Class II · Moderate risk Terminated
Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count box, Rx only, Manufacturer: Arzol…
Reason cGMP deviations: Temperature abuse
Class I · High risk Terminated
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count…
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk Terminated
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package…
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Class III · Low risk Terminated
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL…
Reason Defective container: Ineffective seal between the cap and jar of the affected product.
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