PRO POWER MAX Energy Capsules Recalled for Undeclared Sildenafil and Tadalafil
Fabscout Entertainment is recalling PRO POWER MAX Natural Energy Enhancer capsules because they contain undeclared sildenafil and tadalafil and were marketed without FDA approval.
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 is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death. The presence of undeclared prescription drug ingredients in an unapproved supplement poses a significant risk of serious adverse health consequences.
Plain-English summary
Fabscout Entertainment, Inc. is recalling PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS. The product is supplied in 1 capsule per blister pack, with 18 blister packs per unit. It is distributed by MSH Distribution LLC.
The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was found to contain undeclared sildenafil and tadalafil. These are active ingredients in prescription medications used to treat erectile dysfunction and pulmonary arterial hypertension, respectively.
The recall affects all lots of the product. Distribution was limited to California, Florida, and Utah. Consumers should stop using the product and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
- Manufacturer
- Fabscout Entertainment, Inc
- Category
- Drug — Dietary Supplement
- Affected units
- 18
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
Part of a larger recall action
This product is one of 3 recalled by Fabscout Entertainment, 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.
See all 3 products in this recall →Related recalls
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