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.
What this means for you
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
- Hazard
- damaged-product
- cgmp-deviation
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:
- PR
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