BLACK LABEL X capsules recalled over undeclared sildenafil
- Recall date
- April 29, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Making It a Lifestyle recalls BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
- Recall number
- D-0220-2017
- FDA classification
- Class I
- Brand / firm
- Making It a Lifestyle
- Sold / distributed
- Nationwide
Why it was recalled
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
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
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
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