UP2 Libido Supplement Recalled for Undeclared Sildenafil
Med Man Distribution is recalling UP2 dietary supplements because FDA analysis found undeclared sildenafil, a prescription drug, in the product.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of undeclared sildenafil, a prescription drug, in a dietary supplement poses a significant risk of serious adverse health consequences, particularly for individuals with certain medical conditions or those taking other medications.
Plain-English summary
Med Man Distribution, Inc. is recalling UP2, a dietary supplement marketed as 'All Natural Libido for Men & Women.' The recall involves 1,680 cartons of the product, which are available in one-pack, four-pack, and ten-pack configurations. The product was distributed nationwide in the USA.
The recall was initiated because FDA analysis discovered that the product contains undeclared sildenafil. Sildenafil is a prescription medication, and the presence of this undeclared drug in a dietary supplement means the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased UP2 supplements should stop using the product and contact Med Man Distribution, Inc. for further instructions or a refund. The recall covers all lots of the product.
The recalled product
- Product
- UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
- Manufacturer
- Med Man Distribution, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 1,680
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Med Man Distribution, Inc. 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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