Label reads in part as: "EL ISLE¿O***SOFRITO GOURMET CON SAZON Y ACHIOTE***PESO NETO/NET…
AC Culinary Group LLC recalled this product and the FDA reported the enforcement action on 3 August 2016 as Class II. The recall was initiated by the firm. Undeclared food allergen FD&C Yellow #6.
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
- Label reads in part as: "EL ISLE¿O***SOFRITO GOURMET CON SAZON Y ACHIOTE***PESO NETO/NET WT. ***Keep Refrigerated***Marlin Distributors P.O. Box 8763 Bayamon, PR 00960***HECHO EN PUERTO RICO" Product presentations: 12oz and 32oz
- Reason for recall
- Undeclared food allergen FD&C Yellow #6.
- Recalling firm
- AC Culinary Group LLC
- Firm location
- Catano, Puerto Rico, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1847-2016
- Quantity
- 2892 units
- Distribution
- Puerto Rico only.
- Initiated
- 30 June 2016
- Reported by FDA
- 3 August 2016
- Terminated
- 12 June 2017
- Firm notified by
- Letter
- Product codes
- 12 oz presentation: LOT: 28J, EXP: 12/16 32 oz presentation: LOT: 31R JN, EXP: 09/16
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 11 months, from 30 June 2016 to termination on 12 June 2017. 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 5 weeks 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.
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.
Other records from AC Culinary Group LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2019-12-18 | Chef Pineiro's Ajo con Cilantro, with Coriander, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
| 2019-12-18 | Chef Pineiro's Sofrito con Albahaca, with Basil, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
| 2019-12-18 | Chef Pineiro's Ajo con Albahaca, with Basil, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
| 2019-12-18 | Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | The firm received a customer complaint describing a metal filament in a bottle of one lot of Sofrito Cilantro 32 oz. Further investigation determined that the same type of metal filament was found in raw material (dehydrated minced onion) used in the manufacture of Sofrito Cilantro 32 oz and other products. | Class II |
All 5 records for AC Culinary Group LLC.
All 2016 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.