Recall Radar

Lopez Gonzalez Santana recalls BTREX PLUS and 1 more: label issue

June 23, 2021 · Lopez Gonzalez Santana Class III

Class IIIFDA’s lowest-risk class: use of the product is not likely to cause adverse health consequences.
Reason for the recallCGMP Deviations: Presence of damaged tablets

Find the official FDA enforcement report

Recall at a glance

Recalling company
Lopez Gonzalez Santana
Location
Rio Piedras, PR
Reported by FDA
June 23, 2021
Recall started
May 25, 2021
Risk class
Class III
Status (latest data we have)
Terminated
Type
Voluntary: Firm initiated
Category
Supplements and infant formula
Reason type
Labeling and quality

Is my product affected?

Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.

  • BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801
    Quantity: 894 bottles
    Codes: Lot #30636, Expiration Date 01/2022
  • BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples)
    Quantity: 4641 units (2 tablet bottles)
    Codes: Lot #30637, Expiration Date 01. 2022

Where it was distributed

Domestic distribution only-PR

What to do

If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.

Frequently asked questions

What was recalled?

Lopez Gonzalez Santana recalled 2 products, including BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801.

Why was it recalled?

CGMP Deviations: Presence of damaged tablets

What does Class III mean?

FDA’s lowest-risk class: use of the product is not likely to cause adverse health consequences.

Where was it sold or shipped?

Domestic distribution only-PR

What should I do if I have this product?

Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.

More recalls from Lopez Gonzalez Santana

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Sources

Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.