Titanium 4000 capsules recalled for undeclared sildenafil and tadalafil
D.B.P. Distribution is recalling Titanium 4000 capsules because they contain undeclared sildenafil and tadalafil and were marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
D.B.P. Distribution is recalling Titanium 4000 capsules, 4000 mg, 1 count blister card, 30 blister display box, UPC 86077000020. The product was distributed nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sildenafil and tadalafil. The source text does not specify the quantity of units recalled or report any specific illnesses or injuries.
Consumers should stop using the product and contact D.B.P. Distribution for further instructions or a refund.
The recalled product
- Product
- Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
- Manufacturer
- D.B.P. Distribution
- Category
- Drug — Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Expiration 12/29/2020
Distribution
Distributed nationwide across the United States.
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