F-0540-2021 Class III Terminated

Recalled by Lopez Gonzalez Santana Corporation — Rio Piedras, PR

FDA food recall F-0540-2021 was initiated by Lopez Gonzalez Santana Corporation on Jul 13, 2020 and is designated Class III. Reason for recall: CGMP Deviations: Presence of damaged tablets The recall status is terminated (terminated Oct 8, 2021). Affected quantity: lots #32179  1405 and Lot #33278 - 0.

Recall Details

Product Type
Food
Report Date
May 26, 2021
Initiation Date
Jul 13, 2020
Termination Date
Oct 8, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
lots #32179  1405 and Lot #33278 - 0.

Product Description

BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)

Reason for Recall

CGMP Deviations: Presence of damaged tablets

Distribution Pattern

Domestic distribution only-PR

Code Information

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

Source

Dataset
openFDA food recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for F-0540-2021
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 8, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for F-0540-2021. Report a data issue: hello@regdatalab.com.