FDA Recalls Panther Platinum 30000 Capsules for Unapproved Tadalfil Content
Motto International Corp is recalling Panther Platinum 30000 Capsules because FDA analysis found the product contains tadalfil and 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 mandates a severity score of 5 per the rubric.
Plain-English summary
Motto International Corp is recalling Panther Platinum 30000 Capsules. The product is packaged in green, black background with white, red text in hologram paper packaging, available in 2, 4, and 10 count blister cards. The recall covers all lots remaining within expiry.
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 tadalfil, an active ingredient not listed on the label.
The product was distributed in Texas. Consumers who possess this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
- Manufacturer
- Motto International Corp
- Category
- Drug — Unapproved Supplement
- Affected units
- 1
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.
See all 4 products in this recall →Related recalls
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