Thumbs Up 7 Red Capsules Recalled for Undeclared Active Pharmaceutical Ingredients
Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules because they contain undeclared tadalafil and/or sildenafil and vardenafil, making them unapproved drugs with unestablished safety and efficacy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I because the product is marketed as an unapproved drug containing undeclared active pharmaceutical ingredients (tadalafil, sildenafil, and vardenafil) with unestablished safety and efficacy. Per the rubric, FDA Class I recalls are never scored below 4.
Plain-English summary
Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules distributed nationwide. The 10-count boxes (163 boxes total) were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The capsules contain undeclared tadalafil and/or sildenafil and vardenafil. These are prescription pharmaceutical ingredients whose safety and efficacy have not been established for this product, making it an unapproved drug subject to recall.
Consumers who have purchased this product should stop using it and dispose of it safely. Those with health concerns should consult their healthcare provider.
The recalled product
- Product
- Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
- Manufacturer
- Ummzy, LLC
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 within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ummzy, LLC 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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