Hacienda Las Glorias Premium, Bebida de Parcha (Passion Fruit Drink) 16 Oz. (480 ML)
San Mar Manufacturing Corporation recalled this product and the FDA reported the enforcement action on 29 December 2021 as Class II. The recall was initiated by the firm. Undeclared Yellow #5
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
- Hacienda Las Glorias Premium, Bebida de Parcha (Passion Fruit Drink) 16 Oz. (480 ML)
- Reason for recall
- Undeclared Yellow #5
- Recalling firm
- San Mar Manufacturing Corporation
- Firm location
- Catano, Puerto Rico, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0351-2022
- Quantity
- 27 boxes/24 units ea.
- Distribution
- Domestic distribution only.
- Initiated
- 8 December 2021
- Reported by FDA
- 29 December 2021
- Terminated
- 16 March 2022
- Firm notified by
- Letter
- Product codes
- Lote: 956 and Lote: 973
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 3 months, from 8 December 2021 to termination on 16 March 2022. 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 3 weeks after the firm began the recall.
- Recalls of a beverage or juice run a median of 6 months, so this one was shorter than usual for its category. Juice is the other food with its own HACCP regulation in the United States, 21 CFR part 120, which requires a treatment achieving a 5-log reduction of the pertinent pathogen, and unpasteurised juice recalls are almost always a failure of that step or an exemption misapplied.
What this recall was for
Undeclared allergens
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.135(c)(2)
- Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
- 21 CFR 101.4
- Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Filed under beverages and juice. A product can sit in more than one.
Other beverages and juice recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2021 recalls · All FDA food recall data
21 CFR 117.135(c)(2) is the clause behind this recall, and it is one 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.