The Recall Desk
LowFDA (Food)·F-0540-2021·Announced 2021-05-26

Lopez Gonzalez Santana Recalls BTREX PLUS Dietary Supplement Due to Damaged Tablets

Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement caplets due to the presence of damaged tablets, a Current Good Manufacturing Practice (CGMP) deviation.

What this means for you

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 hazard is a cosmetic/quality defect (damaged tablets) rather than a safety risk.

Plain-English summary

Lopez Gonzalez Santana Corporation is voluntarily recalling BTREX PLUS, a dietary supplement containing 2 caplets, under FDA recall number F-0540-2021. The recall is limited to specific lots: Lot #32179 with an expiration date of 9/2022 and Lot #33278 with an expiration date of 12/2022. The product is identified by UPC 05380930802 and was distributed domestically in Puerto Rico as physician samples.

The reason for the recall is a Current Good Manufacturing Practice (CGMP) deviation involving the presence of damaged tablets. The FDA has classified this recall as Class III, indicating that there is a remote possibility that adverse health consequences could be caused by the use of or exposure to the product.

Consumers who have purchased or received these specific lots of BTREX PLUS should stop using the product and contact the recalling firm for further instructions or a refund. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
Manufacturer
Lopez Gonzalez Santana Corporation
Category
Drug — Dietary Supplement
Hazard

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 (3)

  • Lot# 32179
  • Exp. 9/2022 Lot# 33278
  • Exp. 12/2022

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

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