Titanium 4000 recalled over undeclared sildenafil
- Recall date
- April 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- D.B.P. Distribution recalls Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 860770…
- Recall number
- D-1292-2019
- FDA classification
- Class I
- Brand / firm
- D.B.P. Distribution
- Sold / distributed
- Nationwide.
Why it was recalled
Marketed without an approved NDA/ANDA: undeclared sildenafil 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
Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
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