Lopez Gonzalez Santana Recalls BTREX PLUS Dietary Supplement Due to Damaged Tablets
Lopez Gonzalez Santana Corporation is recalling 662 bottles of BTREX PLUS dietary supplement because of damaged tablets. The product was distributed in Puerto Rico.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a cosmetic/quality defect (damaged tablets) with no reported injuries.
Plain-English summary
Lopez Gonzalez Santana Corporation is voluntarily recalling 662 bottles of BTREX PLUS, Dietary Supplement 100 Caplets. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of damaged tablets in the product.
The affected product is identified by Lot # 33491 and has an expiration date of 12/22. The distribution was limited to domestic Puerto Rico (PR). The FDA has classified this recall as Class III, indicating that there is a remote probability that adverse health consequences would be caused or aggravated by the use of the product.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund. The recall is driven by quality control standards regarding the physical integrity of the tablets rather than a reported safety incident or contamination.
The recalled product
- Product
- BTREX PLUS, Dietary Supplement 100 Caplets
- Manufacturer
- Lopez Gonzalez Santana Corporation
- Category
- Food — Dietary Supplement
- Affected units
- 662
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 (2)
- Lot # 33491
- Exp. 12/22
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Lopez Gonzalez Santana Corporation under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Lopez Gonzalez Santana Corporation
See all →- LowBTREX PLUS Dietary Supplement Recalled for Damaged Tablets
FDA (Food) · 2021-06-23
- LowBTREX PLUS Dietary Supplement Recalled for Damaged Tablets
FDA (Food) · 2021-06-23
- LowLopez Gonzalez Santana Recalls BTREX PLUS Dietary Supplement Due to Damaged Tablets
FDA (Food) · 2021-05-26
- LowBTREX PLUS Dietary Supplement Recalled for Damaged Tablets
FDA (Food) · 2021-05-19
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