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Class III: unlikely to cause harmTerminated

Lopez Gonzalez Santana Btrex Plus Recall

BTREX PLUS, Dietary Supplement 100 Caplets

Lopez Gonzalez Santana Corporation · Rio Piedras, PR

Risk level
Class III
Reported by FDA
Jun 23, 2021
Recall ID
F-0665-2021
Check your lot numberHow we source this data

Summary

Lopez Gonzalez Santana recalled Btrex Plus starting May 25, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-0665-2021 on Jun 23, 2021. Reason: CGMP Deviations: Presence of damaged tablets. Status: Terminated.

Why it was recalled

CGMP Deviations: Presence of damaged tablets

Product description

BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801

Lot numbers, UPCs & expiration codes

Lot #30636, Expiration Date 01/2022

Where it was sold

Domestic distribution only-PR

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0665-2021
Classification
Class III
Status
Terminated
Recall initiated
May 25, 2021
FDA report date
Jun 23, 2021
Quantity
894 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Lopez Gonzalez Santana Corporation

Original FDA data

Every field from FDA enforcement report F-0665-2021, exactly as published.

Show all FDA fields
City
Rio Piedras
State
PR
Status
Terminated
Country
United States
Event ID
88029
Address
Calle De Diego # 488 Altos
Code information
Lot #30636, Expiration Date 01/2022
Postal code
00924
Report date
Jun 23, 2021
Product type
Food
Recall number
F-0665-2021
Classification
Class III
Recalling firm
Lopez Gonzalez Santana Corporation
Product quantity
894 bottles
Termination date
Jan 20, 2022
Reason for recall
CGMP Deviations: Presence of damaged tablets
Voluntary / mandated
Voluntary: Firm initiated
Product description
BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801
Distribution pattern
Domestic distribution only-PR
Recall initiation date
May 25, 2021
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Jun 11, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0665-2021, published Jun 23, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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