BTREX PLUS Dietary Supplement Recalled for Damaged Tablets
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement 2-caplet bottles (Lot #30637, expiration 01.2022) due to the presence of damaged tablets resulting from Current Good Manufacturing Practice (CGMP) deviations.
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: This is an FDA Class III recall involving a manufacturing/process deviation (damaged tablets) with no reported illnesses, injuries, or safety hazards explicitly stated. The issue is a quality/integrity defect rather than a contamination or toxicological hazard, meeting the criteria for a Low severity classification.
Plain-English summary
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS, a dietary supplement product distributed as 2-caplet bottles with UPC 05380930802, specifically physician samples. The recall affects Lot #30637 with an expiration date of January 2022. A total of 4,641 units (2-tablet bottles) were distributed.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the presence of damaged tablets in the product. Damaged tablets may affect the integrity and proper delivery of the dietary supplement.
The product was distributed domestically in Puerto Rico only. Consumers who have purchased this product should discontinue use. Those with questions or concerns should contact their healthcare provider or the manufacturer.
The recalled product
- Product
- BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples)
- Manufacturer
- Lopez Gonzalez Santana Corporation
- Category
- Drug — Dietary Supplement
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 #30637
- Expiration Date 01. 2022
Distribution
Distributed in 1 state:
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
- LowLopez Gonzalez Santana Recalls BTREX PLUS Dietary Supplement Due to Damaged Tablets
FDA (Food) · 2021-05-26
- 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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