Class IITerminated · reported 2017-12-27

Primera Negra, Artificial Vanilla Flavoring NET WT 4 OZ and 8 OZ

GONZALEZ WHOLESALE DISTRIBUTOR,L recalled this product and the FDA reported the enforcement action on 27 December 2017 as Class II. The recall was initiated by the firm. Product contains Coumarin.

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: Primera Negra, Artificial Vanilla Flavoring NET WT 4 OZ and 8 OZ
Reason for recall: Product contains Coumarin.
Recalling firm: GONZALEZ WHOLESALE DISTRIBUTOR,L
Firm location: Sanford, Florida, United States
Classification: Class II
Status: Terminated
Recall number: F-0570-2018
Quantity: 25 cases/24 units ea.
Distribution: Florida consignees only.
Initiated: 28 August 2017
Reported by FDA: 27 December 2017
Terminated: 3 July 2019
Firm notified by: Telephone
Product codes: Lot 07 2016; Exp Date: Dec 2017

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 22 months, from 28 August 2017 to termination on 3 July 2019. 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 months after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

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Early access

Recall 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.