Thumbs Up 7 Red 70K Recalled for Unapproved Sildenafil and Tadalafil
Antoto-K is recalling Thumbs Up 7 Red 70K because FDA analysis found unapproved sildenafil and tadalafil. The product was marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric. The presence of unapproved prescription medications (sildenafil and tadalafil) in a product marketed without approval poses a significant health risk.
Plain-English summary
Antoto-K is recalling 200 cartons of Thumbs Up 7 Red 70K, 10 count blister pack cartons. The product is distributed by Ummzy LLC., made in the USA, and identified by UPC 6 17135 89467 3. The recall covers all lots within expiry and was distributed nationwide.
The recall was initiated because FDA analysis results obtained the presence of sildenafil and tadalafil. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Sildenafil and tadalafil are prescription medications that can have serious side effects, particularly when taken without medical supervision or in combination with other medications.
Consumers who have purchased Thumbs Up 7 Red 70K should stop using the product immediately. They should contact the recalling firm, Antoto-K, or their healthcare provider for further instructions on how to dispose of the product safely. No specific lot numbers or expiration dates are provided in the source text, so consumers should check their packaging for the UPC and product name to determine if they are affected.
The recalled product
- Product
- Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
- Manufacturer
- Antoto-K
- Category
- Drug — Unapproved Supplement
- Affected units
- 200
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.
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