Super Samurai-X recalled over undeclared sildenafil
- Recall date
- May 12, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- SOS Telecom Inc. recalls Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
- Recall number
- D-0104-2017
- FDA classification
- Class I
- Brand / firm
- SOS Telecom Inc.
- Sold / distributed
- NY
Why it was recalled
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
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