Class IICompleted · reported 2021-11-24

Carolina Ingredients Beef Gravy Mix Non-allergen N715025 Net Wt. 50 lbs. Mfr.

Carolina Ingredients recalled this product and the FDA reported the enforcement action on 24 November 2021 as Class II. The recall was initiated by the firm. The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab for evaluation. Some samples were found with elevated lead levels

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: Carolina Ingredients Beef Gravy Mix Non-allergen N715025 Net Wt. 50 lbs. Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
Reason for recall: The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab for evaluation. Some samples were found with elevated lead levels
Recalling firm: Carolina Ingredients
Firm location: Rock Hill, South Carolina, United States
Classification: Class II
Status: Completed
Recall number: F-0160-2022
Quantity: 2,715/50 lb bags
Distribution: All product was shipped to one customer in GA.
Initiated: 7 October 2021
Reported by FDA: 24 November 2021
Firm notified by: Letter
Product codes: Lot #12771, N715025, 715025, Mfr. Date 09/24/2020, Best By 03/24/2021 Lot #27336, N715025, 715025, Mfr. Date 10/05/2020, Best By 04/05/2021 Lot #27366, N715025, 715025, Mfr. Date 10/08/2020, Best By 04/08/2021 Lot #27554, N715025, 715025, Mfr. Date 10/21/2020, Best By 04/21/2021 Lot #28444, N715025, 715025, Mfr. Date 01/04/2021, Best By 07/04/2021 Lot #28534, N715025, 715025, Mfr. Date 01/13/2021, Best By 07/13/2021 Lot #29322, N715025, 715025, Mfr. Date 03/15/2021, Best By 09/15/2021 Lot #29569, N715025, 715025, Mfr. Date 04/07/2021, Best By 10/07/2021 Lot #30884, N715025, 715025, Mfr. Date 07/27/2021, Best By 01/27/2022 Lot #31078, N715025, 715025, Mfr. Date 08/11/2021, Best By 02/11/2022

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 is one of 6 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. All 6 of them are listed on this page.
This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
The FDA published the enforcement report 7 weeks after the firm began the recall.
Most meat and poultry is regulated by USDA FSIS rather than the FDA, so a product appearing in this FDA dataset is usually a closed-faced sandwich, a product with meat as a minor ingredient, or a food FSIS does not claim.

What this recall was for

Chemical contamination

A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.

A preventive controls plan covers chemical contamination 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 117.35(b): Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
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.
21 CFR 117.130(b)(1)(ii): Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.

Filed under meat and poultry. A product can sit in more than one.

Every product in this recall

The FDA opened 6 enforcement records for this one recall, one per product code. This page carries all of them; the 5 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.

The other 5 records of FDA event 88833
Reported	Product	Firm	Reason	Class
2021-11-24	Carolina Ingredients Smoked Peppered Bacon Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Sweet Chipotle Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Jalapeno Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Mustard & Onion Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Avocado Lime Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II

Other meat and poultry 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.

Reported	Product	Firm	Reason	Class
2024-08-14	1- Name: Carbon Steel Utility Kitchen Knife Model: CSK1700 Size: Total length: 10.25" Type of packaging: Each knife packed in a single box 2- Name: Carbon Steel Utility Kitchen Cleaver Knife Model: CSK1701 Size: Total length: 10.5" Type of packaging: Each knife packed in a single box 3- Name: Carbon Steel Utility Kitchen Knife Model: 501141 Size: Total length: 9.5" Type of packaging: Each knife packed in a single box 4- Name: Burnt Bone & Carbon Steel Ulu Knife Model: 2432 Size: Total length: 4" Type of packaging: Each knife packed in a single box 5- Name: Rosewood Carbon Steel Ulu Knife Model: 501204 Size: Total length: 4" Type of packaging: Each knife packed in a single box 6- Name: Rosewood Carbon Steel Meat Cleaver Model: 501172 Size: Total length: 10.25" Type of packaging: Each knife packed in a single box Knives sold direct to consumers via Bespoke Post.	Black Forge Knives	Products contain elevated levels of lead.	Class II
2023-11-22	Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in fiber boxes, net wt. 11 lbs. per box. individual units were sold by weight at the point of sale. Product of Fiji, and imported by Tokai Denpun USA INC. Bellevue, WA. Vacuum package label is read in parts: Product of Fiji - Frozen Tuna Ground Meat, Keep Frozen.	Tokai Denpun USA Inc	Histamine, high total plate count, coliforms, and E.coli (serotype is unknown).	Class II
2023-03-01	Taco Meat Seasoning 1 OZ, 1 LB, 1.5 LBS, 2 LBS, 5 LBS, 6 LBS	Tampico Spice Company Inc	Product was found to have an elevated amount of Aflatoxin	Class II
2022-01-05	Tuna, raw sold at meat counter and wrapped in butcher paper at point of purchase.	Sant' Elia Operations, LLC	Tuna tested above 50 ppm histamine.	Class II
2021-11-24	Carolina Ingredients Smoked Peppered Bacon Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-03-17	Al-Riyan Tuna Meat in Vegetable oil 7 oz. can 48 cans per case	GREEN CITY DISTRIBUTION	High levels of histamines	Class II
2021-01-27	Frozen Tuna Ground Meat - Khee Trading Brand Product of Vietnam 22 Lb. Cartons (2 x 11 lb.)	Khee Trading, Inc.	Potential elevated levels of histamine.	Class II
2020-02-05	Frozen Yellowfin Tuna, Product of Vietnam, Packaged under the following brands and cuts: Tidal Seafood Tuna Round Steak, size 6 - 8 oz, Size 8 - 10 oz, pack 2X10 lbs; and Sea Mart PREMIUM FROZEN YELLOWFIN TUNA LOINS 5-8 LBS IVP, 30 LBS; Sea Mart GRADE AAA FROZEN YELLOWFIN TUNA SAKU 12-16 IVP, 10 LBS; Sea Mart PREMIUM FROZEN YELLOWFIN TUNA STEAKS 8 OZ IVP, 10 LBS; Sea Mart GRADE AAA TUNA CUBE 0.8 OZ IVP, 10 LBS; and PACIFICA FROZEN SEAFOODS, Tuna Round Steak Size 6 OZ IVP, 20 LBS; Tuna Round Steak Size 8 OZ IVP, 20 LBS; J DELUCA FISH COMPANY, INC. TUNA LOIN CC 5 -8 LBS IVP, 30 LBS; TUNA CUBE SIZE 1 INCH IVP, 10 LBS; TUNA SAKU 10-12 OZ IVP, 10 LBS; TUNA SAKU 12-16 OZ IVP, 10 LBS; and Packaged under the FULL MOON FISH Brand - TUNA LOIN 1-3 LBS IVP, 30 LBS; TUNA LOIN 3 -5 LBS IVP 30 LBS; TUNA LOIN 5- 8 LBS IVP 30 LBS; TUNA STEAK 4 OZ IVP, 10 LBS; TUNA STEAK 6 OZ IVP, 10 LBS; TUNA STEAK 8 OZ IVP, 10 LBS; TUNA SAKU 8 -12 OZ IVP, 10 LBS; TUNA SAKU 12-16 OZ IVP, 10 LBS; FROZEN YELLOWFISH TUNA CUBE 2.8 CM IVP, 10 LBS; and TUNA KING brand - TUNA LOIN 5 -8 LBS IVP, 30 LBS; TUNA MEDALLIONS 2-3 OZ IVP, 10 LBS; TUNA STEAK 4 OZ IVP, 10 LBS; TUNA STEAK 6 OZ IVP, 10 LBS; TUNA STEAK 8 OZ IVP, 10 LBS; TUNA SAKU 12-16 OZ IVP, 10 LBS; and MiCal SEAFOOD Brand: Tuna Loins AAA 3-5LB IVP, 30lb; Tuna Loins AAA 5-8 LB IVP, 30 lb.; Tuna POKE AAA 1.5 cm IVP and 2cm IVP, 10 lb.; Tuna Steaks AAA, 4oz, 6oz, 8oz, 1 oz, 10 lb., IVP and Tuna Steaks AA 4oz, 6oz, 8oz, 10 oz, 10 lb.; Tuna Ground Meat AAA IVP, 10 lb.; Tuna Saku AAA 8-12 OZ IVP, 10 lb., Tuna Saku 12-16 oz IVP, 10lb. .	Truong Phu Xanh Co.,	Elevated histamine levels.	Class II

Other records from Carolina Ingredients

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.

Reported	Product	Firm	Reason	Class
2021-11-24	Carolina Ingredients Smoked Peppered Bacon Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Sweet Chipotle Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Jalapeno Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Mustard & Onion Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II
2021-11-24	Carolina Ingredients Avocado Lime Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730	Carolina Ingredients	The firm was notified by their customer of possible lead in their products. The firm sent samples of the product to a lab	Class II

All 6 records for Carolina Ingredients

All 2021 recalls · All FDA food recall data

21 CFR 117.35(b) 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 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.