BTREX PLUS, Dietary Supplement 100 Caplets
Lopez Gonzalez Santana Corporation recalled this product and the FDA reported the enforcement action on 19 May 2021 as Class III. The recall was initiated by the firm. cGMP Deviation: Presence of damaged tablets
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- BTREX PLUS, Dietary Supplement 100 Caplets
- Reason for recall
- cGMP Deviation: Presence of damaged tablets
- Recalling firm
- Lopez Gonzalez Santana Corporation
- Firm location
- Rio Piedras, Puerto Rico, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0484-2021
- Quantity
- 311 Bottles
- Distribution
- Domestic distribution only-PR
- Initiated
- 20 April 2021
- Reported by FDA
- 19 May 2021
- Terminated
- 8 October 2021
- Firm notified by
- Product codes
- Lot # 33277 Exp date:12/22
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 6 months, from 20 April 2021 to termination on 8 October 2021. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 4 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Lopez Gonzalez Santana Corporation
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2021-06-23 | BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801 | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
| 2021-06-23 | BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples) | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
| 2021-05-26 | BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples) | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
| 2021-05-26 | BTREX PLUS, Dietary Supplement 100 Caplets | Lopez Gonzalez Santana Corporation | CGMP Deviations: Presence of damaged tablets | Class III |
All 5 records for Lopez Gonzalez Santana Corporation
All 2021 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.