Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)

FDA recall notice · announced March 26, 2014 · Fabscout Entertainment

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)

Reason for recall

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.

Notes

Distribution: Nationwide and France
Lot/code information: All lots
Status: Terminated
Products in this recall event:
- Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) (D-1169-2014)
- Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language) (D-1170-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.