PapaZen 3300 capsule recalled over undeclared active
- Recall date
- September 15, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Gadget Island, Inc recalls PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718…
- Recall number
- D-0104-2018
- FDA classification
- Class I
- Brand / firm
- Gadget Island, Inc
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
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
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
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