FDA Recalls Unapproved Bull Platinum 30000 Capsules Containing Tadalafil
Motto International Corp is recalling Bull Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, a prescription drug, and it was 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 per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Motto International Corp is recalling Bull Platinum 30000 Capsules, 1000 mg, packaged in 2, 4, and 10 count blister cards. The product is described as having an orange, white, and yellow background with silver text. The recall involves 8 boxes of the product.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains tadalafil, an active ingredient found in prescription medications. The recall covers all lots remaining within their expiration dates.
The product was distributed in Texas. Consumers who possess this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX
- Manufacturer
- Motto International Corp
- Category
- Drug — Unapproved Supplement
- Affected units
- 8
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)
- All lots remaining within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Motto International Corp under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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