Mezcal Drinking Cups Recalled for Risk of Leaching Lead

Del Maguey Co., New York, NY is conducting a voluntary recall of certain ceramicware cups called copitas – small artisan cups traditionally used for drinking mezcal – because they may exceed FDA guidance levels for leachable lead.

The copitas were distributed free-of-charge to consumers at retail locations, events and tastings across the United States. Copitas were also included in value-added packs (VAPs) sold by retail stores since October 2022; the VAPs included a 750ml bottle of Del Maguey Vida de Muertos mezcal and 4 copitas. This recall covers all copitas distributed by Del Maguey to date.

The cup is made of red clay, with applied enamel on the surface that holds liquid inside. It holds a maximum of 1 oz, and measures 2.5 inches wide and 1 inch in height. The copitas can be identified by the embossed brand name “Del Maguey Single Village Mezcal” which encircles the word “Mexico” located on the inside of the cup. Images of the copitas and the VAPs sold at retail are pictured below.

"To date, no complaints of illness or injury related to usage of the copitas have been reported."  For one, I'm not sure the average consumer would recognize they are suffering the effects of lead poisoning with identifying the cups as the source.  Secondly, in order to get sufficient amount of lead ingested, one would probably have to consume an awful lot of mezcal, to the point where the alcohol consumed would be a bigger issue.  It is not like they are storing the booze in the cup.  Certainly not the same risk posed to ancient Romans who stored wine in leaden vessels.  But you never know.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/del-maguey-issues-voluntary-recall-promotional-ceramicware-cups-called-copitas-used-drinking-mezcal
Del Maguey Issues Voluntary Recall of Promotional Ceramicware Cups Called ‘Copitas’ -- Used for Drinking Mezcal Because of Possible Health Risk
Summary
Company Announcement Date:  May 01, 2023
FDA Publish Date:  May 01, 2023
Product Type:  Food & Beverages
Reason for Announcement:  May exceed FDA guidance levels for leachable lead.
Company Name:  Del Maguey Co.
Brand Name:  Del Maguey
Product Description:  Copitas-Artisan ceramicware cups

FDA Issues Warning Letter to MI Processor of RTE Seasoned Pretzels

FDA issued a Warning Letter to Pop Daddy Popcorn Whitmore Lake, MI a processor of ready-to-eat (RTE) seasoned hard pretzels.  The Warning Letter included the following items:

Did not identify environmental pathogens as a food safety hazard in processing of RTE product with exposure.

• "Did not consider contamination with environmental pathogens as a potential food safety hazard at the Mixing or Packaging/Sealing step to evaluate whether it requires a preventive control."

Examples of poor practices when handling RTE food 

"an employee was observed to touch an electrical control panel (which is not cleaned between production runs within a production day), dump a tumbler filled with RTE seasoned pretzels into a plastic bucket, scoop a handful of these seasoned pretzels from the bucket with their gloved hand, and place them back into the tumbler. The same employee then proceeded to open a box of pretzels including the interior bag and scoop those pretzels with a gloved hand into a plastic pitcher before placing those pretzels into the tumbler."

"During production of Pop Daddy Dill Pickle pretzels (Lot # 22822.1), plastic buckets containing RTE seasoned pretzels were sitting atop flattened cardboard on the floor. A bucket was observed slightly overhanging the cardboard and partially exposed to the floor. An employee’s hands were observed to touch the bottom of the buckets while emptying them into a packaging hopper, in the process also touching the inside of the buckets. The employee then placed the buckets under the mixing tumbler to fill with the next batch of RTE seasoned pretzels, without the buckets being washed or sanitized."

Did not verify the effectiveness of this preventive control by performing environmental monitoring 

• "We note that your SOP titled “Environmental Monitoring,” dated October 24, 2018, states that you must (b)(4) take sample swabs at various points of the production process. However, during the inspection your management told FDA investigators that you do not recognize environmental swabbing as a verification of your sanitation controls. In addition, your environmental monitoring SOP did not identify the number of sites to be tested during routine environmental monitoring, the timing for collecting samples, or the test(s) conducted including the analytical method(s) used, as required by 21 CFR 117.165(b)(3)(iii-v)."
• "Did not always follow your procedure. A review of your environmental monitoring results from 2020, 2021, and 2022 (in which you collected (b)(4) swabs respectively on (b)(4) as part of your routine sampling program) found that you frequently obtained results that exceeded your TPC limit of (b)(4) cfu/swab. For example, your 2021 environmental monitoring obtained results of (b)(4) cfu on (b)(4), (b)(4) cfu on (b)(4), and (b)(4) cfu on (b)(4) for the (b)(4) faucet handle. Also, your 2022 environmental monitoring obtained results of (b)(4) cfu on (b)(4) and (b)(4) cfu on (b)(4) for the warehouse worktable. In both cases, upon obtaining unacceptable TPC results, you took follow-up samples, which still indicated unacceptable TPC levels. There is no indication that you took any further action to bring the TPC level down to an acceptable level."

Supplier Preventive Controls for ingredients used in RTE applications

• The "pretzel hazard analysis in your food safety plan, dated March 21, 2022, did not consider pathogens such as Salmonella in your RTE seasoning ingredients to determine whether they require a preventive control. Your process does not apply a lethal treatment to any of your incoming raw materials and ingredients used in production of your RTE pretzels. Some of these seasoning ingredients (e.g., garlic parmesan, dill, and cinnamon) have been associated with pathogens such as Salmonella. 
•  During the inspection, the most recent survey and audit certificate from (b)(4), your supplier for garlic parmesan seasoning, was reviewed. However, the certificate was issued on May 11, 2021, so it was already three months past the annual audit timeframe required by your supply-chain procedure when we reviewed the certificate. Salmonella in RTE pretzels is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least (b)(4) thereafter (see 21 CFR 117.430(b)(1)(ii)).

Allergen Preventive Controls

• The "inspection revealed that your preventive controls qualified individual (or an individual under the oversight of your preventive controls qualified individual) was not reviewing your allergen monitoring records to verify that the label checks were operating as intended"

WARNING LETTER
Pop Daddy Popcorn, LLC
MARCS-CMS 646807 — MARCH 28, 2023

FDA Releases Investigation Report on 2022 Salmonella Outbreak Associated with Cantaloupe

FDA released a report on a 2022 Salmonella outbreak that was linked to cantaloupe.  A recall or public health advisory had not been issued at the time because the investigation took longer than the cantaloupe was available for sale.

The investigation did not find a definitive source for the Salmonella strain found in the outbreak, although a common  packinghouse was identified.  The report does give some broad recommendations that packing houses, as well as farms, should be following.   Key among these, from my perspective, developing written procedures (SOPs) for the operation based upon reducing risk and then following these procedures with documentation.  It seems that this was the biggest knock against the firm in this investigation.

https://www.fda.gov/food/outbreaks-foodborne-illness/factors-potentially-contributing-contamination-cantaloupe-implicated-outbreak-salmonella-typhimurium
Factors Potentially Contributing to the Contamination of Cantaloupe Implicated in the Outbreak of Salmonella Typhimurium During the Summer of 2022

Full Report - https://www.fda.gov/media/167640/download

In August 2022, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and state partners conducted an outbreak investigation into a multistate outbreak of  Salmonella Typhimurium linked to cantaloupe.
• Total Illnesses: 87
• Hospitalizations: 32
• Deaths: 0
• Last Illness Onset: September 11, 2022
• States with Cases: GA (1), IL (5), IN (17), IA (38), KY (3), MI (3), MN (4), MO (2), OH (3), SC (1), WI (10)

The outbreak response investigation found:
1) In August 2022, CDC notified FDA about a multistate cluster of Salmonella Typhimurium illnesses 
with a potential signal for melon exposures. The cases were geographically distributed in the U.S. upper Midwest.
2) The isolates in this cluster of illnesses were within 7 alleles / 11 single-nucleotide polymorphisms 
(SNPs) of two FDA soil swab samples collected from a 2020 outbreak investigation in Indiana. As a part of the 2022 investigation, FDA and state partners collected multiple samples, but none of the resulting isolates were a definitive match to the 2022 outbreak strain.
3) FDA’s 2022 traceback investigation identified 11 points of service, of which 8 traced back to a  common packinghouse. Although a common packinghouse was identified, there was no convergence to a single shipment of products, and therefore three farms that supplied the common packinghouse were identified as potential sources of cantaloupe. 

All Purpose Flour Recalled After Sample Testing Finds Salmonella

General Mills today announced a voluntary national recall of two-, five- and 10-pound bags of its Gold Medal Unbleached and Bleached All Purpose Flour with a “better if used by” date of March 27, 2024, and March 28, 2024 due to the potential presence of Salmonella.  The recall is being issued for the potential presence of Salmonella Infantis,which was discovered during sampling of the five-pound bag product.

 
  

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/general-mills-recalls-four-gold-medal-unbleached-and-bleached-all-purpose-flour-varieties-dated
General Mills Recalls Four Gold Medal Unbleached and Bleached All Purpose Flour Varieties Dated March 27, 2024 and March 28, 2024
Summary
Company Announcement Date:  April 28, 2023
FDA Publish Date:  April 28, 2023
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:  General Mills
Brand Name:  Gold Medal
Product Description:  All Purpose Flour, bleached and unbleached

Public Health Alert Issued for WA Establishment's RTE Soup Produced That is Prematurely Spoiling

USDA-FSIS is issuing a public health alert due to concerns that ready-to-eat meat soup products from Ivars Company of  Mukilteo, WA, may have been prepared, packed, or held under insanitary conditions, which may result in the product spoiling prematurely.  The problem was discovered when the establishment notified FSIS that they had received multiple consumer complaints regarding bloated soup packages. Upon further review, the establishment found that some product spoiled prematurely. The establishment’s lab testing of the prematurely spoiled products found high levels of spoilage bacteria in the products.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-meat-soup-products-due-possible
FSIS Issues Public Health Alert for Ready-to-Eat Meat Soup Products Due to Possible Contamination
IVARS COMMISSARY

Company's Three Commissary Locations Recall Sandwiches After Failing to Input Sesame on Print-and-Apply Labels

GH Foods CA,  GHSW, Houston, TX and GHGA, Conley, GA  are recalling 8.55 oz packages of Turkey and Havarti Sandwiches due to undeclared sesame in bread.  The recall was initiated after it was discovered by a company internal review/audit that sesame in the bread was not declared as an allergen. Sesame was always an ingredient and should have been declared as an allergen starting January 1, 2023 as it was added to the list of the major food allergens.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gh-foods-ca-llc-issues-allergy-alert-undeclared-sesame-turkey-and-havarti-sandwich
GH Foods CA, LLC. Issues Allergy Alert for Undeclared Sesame in Turkey and Havarti Sandwich
Summary
Company Announcement Date:  April 26, 2023
FDA Publish Date:  April 27, 2023
Product Type:  Food & Beverages  Grain/Grain Product
Reason for Announcement:  Product may contain undeclared sesame in bread
Company Name:  GH Foods CA, LLC
Brand Name:  GH Foods CA, LLC
Product Description:  Turkey and Havarti Sandwich

WA Company Recalls Yogurt for Undeclared Egg After Filling Lemon Curd Product Into Vanilla Bean Containers

Ellenos Real Greek LLC of Federal Way, WA is recalling Vanilla Bean Greek Yogurt 4oz. cups, sold in Costco 12-Pack case, item #1340833, because it may contain undeclared egg.  The recall was initiated when a few 4oz cups containing bright yellow puree instead of solid white yogurt with vanilla bean flakes were discovered in Vanilla Bean yogurt cups. After a full internal investigation, it was determined that Vanilla Bean yogurt cups were inadvertently used and packed with Lemon Curd yogurt product. The Vanilla Bean yogurt cup label does not declare egg.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ellenos-real-greek-llc-issues-allergy-alert-undeclared-egg-vanilla-bean-yogurt-4oz-cup-costco-12
Ellenos Real Greek LLC Issues Allergy Alert on Undeclared Egg In Vanilla Bean Yogurt 4oz Cup In Costco 12-Pack
Summary
Company Announcement Date:  April 25, 2023
FDA Publish Date:  April 25, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Product may contain undeclared egg allergen
Company Name:  Ellenos Real Greek LLC
Brand Name:  Ellenos
Product Description:  Greek Yogurt

CO Company Recalls Granola-type Product Due to Undeclared Almonds

American Outdoor Products of Boulder, CO is voluntarily recalling its 4.6 ounce packages of Backpacker’s Pantry Blueberry Peach Crisp because the ingredient statement declares “Almonds”, but the “Contains" statement did not declare “Almond”.  The recall was initiated after it was discovered that “Almond” was included in the ingredients list but was not listed in the “Contains” statement.

One illness has been reported in connection with this problem, to date.

From this posting, it appears the company had produced this product for over 6 months without knowing that almond was in the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-outdoor-products-issues-allergy-alert-undeclared-almonds-backpackers-pantry-blueberry-peach
American Outdoor Products Issues Allergy Alert on Undeclared Almonds in Backpacker’s Pantry Blueberry Peach Crisp
Summary
Company Announcement Date:  April 25, 2023
FDA Publish Date:  April 25, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Product may contain undeclared almonds
Company Name:  American Outdoor Products
Brand Name:  Backpacker’s Pantry
Product Description:  Blueberry Peach Crisp

SD Pretzel Company Expands Recall After Testing Finds More Product with Undeclared Milk

Dakota Style Foods, Inc. is expanding the recall of the braided pretzels to include the following products because they may contain undeclared milk. The initial recall was issued on April 18, 2023.
The initial recall was initiated after a consumer complaint about the product containing undeclared milk.  The recall was expanded after further testing discovered additional products containing milk were distributed in packaging that did not reveal the presence of milk.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dakota-style-foods-inc-issues-expanded-allergy-alert-undeclared-milk-pretzels
Dakota Style Foods, Inc. Issues Expanded Allergy Alert on Undeclared Milk in Pretzels
Summary
Company Announcement Date:  April 21, 2023
FDA Publish Date:  April 22, 2023
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared milk
Company Name:  Dakota Style Foods, Inc.
Brand Name:  Dakota Style, Best Choice and more
Product Description:  Pretzels