QMart Recalls Burro en Primavera Capsules for Unapproved Ingredients
QMart is recalling Burro en Primavera capsules because FDA analysis found unapproved tadalafil and/or sildenafil.
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 under the rubric.
Plain-English summary
QMart is recalling 500 boxes of Burro en Primavera, 2 capsules (UPC 638632431055). The product was distributed nationwide in the United States.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis results indicated the presence of tadalafil and/or sildenafil in the product.
Consumers who have purchased this product should stop using it and contact QMart for further instructions.
The recalled product
- Product
- Burro en Primavera, 2 capsules, UPC 638632431055
- Manufacturer
- QMart
- Category
- Drug — Unapproved Supplement
- Hazard
- Affected units
- 500
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by QMart 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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