Friday, October 4, 2019

FDA Releases New Draft Guidance Chapter - Recall Plan

FDA released a new guidance document on 'recalls' as part of a series of chapters on the FSMA regulation. This new document titled - Chapter 14: Recall Plan provides FDA's current thinking on what you need to do when writing your company's recall plan.
That document can be found here - https://www.fda.gov/media/131287/download

It would be a good idea to review this document to ensure your current plan reflects what FDA states for each of the elements.

NIH Report - 40% Household Bleach Deactivates CWD Prions

A 5-minute soak in a 40% solution of household bleach (6% sodium hypochlorite) decontaminated stainless steel wires coated with chronic wasting disease (CWD) prions, according to a new study by National Institutes of Health scientists. The scientists used the wires to model knives and saws that hunters and meat processors use when handling deer, elk and moose – all of which are susceptible to CWD.

All bleach concentrations tested are based on undiluted Purebright brand bleach considered as 100%, which contains 6% sodium hypochlorite.   So a 40% solution was 20,000 ppm.

Link to study - https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223659

https://www.nih.gov/news-events/news-releases/household-bleach-inactivates-chronic-wasting-disease-prions
Household Bleach Inactivates Chronic Wasting Disease Prions
Strategy Appears Feasible for Decontaminating Hunting, Meat Processing Equipment

Indiana Company Recalls RTE Pork Product After FSIS Samples Test Positive for LM

Fisher Packing Company, a Redkey, Ind. establishment, is recalling approximately 744 pounds of ready-to-eat (RTE) pork products that may be adulterated with Listeria monocytogenes.  The problem was discovered when the firm notified FSIS that a sample of product produced by Fisher Packing Company confirmed positive for the presence of Listeria monocytogenes.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-095-2019-release
Fisher Packing Company Recalls Ready-To-Eat Pork Products Due to Possible Listeria Contamination
Class I Recall
095-2019
Health Risk: High
Sep 28, 2019

Frozen Blackberries Recalled After FDA Testing Finds Norovirus

Cornerstone Premium Foods of Syracuse, New York is recalling a specific lot of product containing frozen blackberries (noted below) due to the potential of being contaminated with Norovirus. FDA testing of frozen blackberries was reported to have tested positive for Norovirus.

This is a concern because many will use berries in RTE applications, including making fruit smoothies.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cornerstone-premium-foods-voluntarily-recalls-frozen-blackberries-due-possible-health-risk-norovirus
Cornerstone Premium Foods Voluntarily Recalls Frozen Blackberries Due to Possible Health Risk of Norovirus
Summary
Company Announcement Date: October 04, 2019
FDA Publish Date: October 04, 2019
Product Type: Food & Beverages Fruit/Fruit Product
Reason for Announcement: Norovirus
Company Name: Cornerstone Premium Foods
Brand Name: Cornerstone
Product Description: Frozen Blackberries

King Arthur Expands Recall of Flour After Testing Finds E. coli Contamination

In association with ADM Milling Company, King Arthur Flour, Inc.,is expanding its recall to include specific lots of its Unbleached All-Purpose Flour (5 lb. & 25 lb.) after sampling found E. coli 026. King Arthur Flour has not received any confirmed reports of illnesses related to this product.  No illness have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/association-adm-milling-co-king-arthur-flour-inc-expands-recall-unbleached-all-purpose-flour-5-lb-25
In Association with ADM Milling Co, King Arthur Flour, Inc. Expands Recall of Unbleached All-Purpose Flour (5 Lb & 25 Lb)
Summary
Company Announcement Date: October 03, 2019
FDA Publish Date: October 03, 2019
Product Type: Food & Beverages Bakery Product/Mix
Reason for Announcement: E. coli O26
Company Name: King Arthur Flour, Inc.
Brand Name: King Arthur Flour
Product Description: Unbleached All-Purpose Flour

Company Expands Recall of Salmon Product Due to Listeria

A NY based company, Euphoria Foods is expanding a recall issued on 9/24/19 to now include all lots of the Captain K tuna product.  The initial recall was only for the lot that tested positive, but like many Listeria recalls, it is found that additional lots must be recalled because the production facility had inadequate controls for Listeria.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/euphoria-fancy-food-inc-recalls-capitan-k-salmon-fillet-due-possible-health-risk-update
Euphoria Fancy Food Inc Recalls “Capitan K Salmon Fillet” Due to Possible Health Risk Update
Summary
Company Announcement Date: October 02, 2019
FDA Publish Date: October 02, 2019
Product Type: Food & Beverages
Reason for Announcement: Listeria monocytogenes
Company Name: Euphoria Fancy Food Inc.
Brand Name: CAPITAN K
Product Description: Salmon slightly salted piece

Company Recalls Tuna After Four Cases of Scombroid Poisoning

Mical Seafood, Inc. of Cooper City, FL, voluntarily initiated a recall of frozen, wild-caught yellowfin tuna poke cubes, tuna loins, tuna ground meat and 6oz tuna steaks because of potentially elevated levels of histamine.

Elevated levels of histamines can produce an allergic reaction called scombroid fish poisoning that may result in symptoms that can generally appear within minutes to several hours after eating the affected fish.

Four reported illnesses have been confirmed as of 10/01/2019. While Mical Seafood feels these were isolated incidents, it has initiated this voluntary recall to take every precautionary measure when it comes to customers’ health and safety.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mical-seafood-inc-recalls-tuna-products-possible-scombroid-poisoning
Mical Seafood Inc Recalls Tuna Products for Possible Scombroid Poisoning
Summary
Company Announcement Date:  October 01, 2019
FDA Publish Date:  October 02, 2019
Product Type:  Food & Beverages   Fish
Reason for Announcement:  Elevated levels of histamine
Company Name:  Mical Seafood, Inc.
Brand Name:  Mical Seafood
Product Description: Yellowfin Tuna

Sandwich Companies Recall Premade Chicken Salad Sandwiches After Supplier of Cooked Chicken Finds Listeria Issue

A number of  companies that make and markets sandwiches are recalling their chicken salad sandwiches due to a Listeria contaminated ingredient.  Northern Tier Bakery of Saint Paul Park, Minnesota, Mrs. Stranttons's,  E.A. Sween,  Coborn's, Inc , Lipari Foods, and Grand Strand Sandwich  are voluntarily recalling chicken salad sandwiches after the cooked chicken supplier, Tip Top Poultry, Inc., a Rockmart, GA, establishment, informed these companies of potential contamination with Listeria monocytogenes.

"The problem was discovered when the firm notified FSIS that multiple samples of product produced by Tip Top Poultry, Inc. confirmed positive for the presence of Listeria monocytogenes after being tested in Canada. The firm decided to recall all cooked, diced or shredded, RTE chicken products produced from January 21, 2019 through September 24, 2019 with product codes ranging from 10000 to 19999 and 70000 to 79999. Tip Top expanded the dates and the scope of the recall out of an abundance of caution."

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-094-2019-release
Tip Top Poultry, Inc. Recalls Ready-To-Eat Poultry Products Due to Possible Listeria Contamination
Class I Recall

094-2019
Health Risk: High
Sep 28, 2019

VT Cheese Company Recalls Cheese Due to Listeria

Consider Bardwell Farm, Whole Foods Market stores in the Northeast and North Atlantic regions are voluntarily recalling Dorset cheese because of a potential contamination of Listeria monocytogenes.

According to the company's own recall notice, the recall was conducted for a number of product types and was done after Listeria was found on product as well as in the processing environment.  No illnesses have been reported.

On the company website, they state that all production has been halted.  Consider Bardwell Farm is located in VT.

Dorset Cheese Voluntarily Recalled by North Atlantic and Northeast Whole Foods Market Stores Due to Possible Health Risk
Summary
Company Announcement Date: September 30, 2019
FDA Publish Date: September 30, 2019
Product Type: Food & Beverages
Reason for Announcement: Potential contamination of Listeria monocytogenes
Company Name: Whole Foods Market
Brand Name: Whole Foods Market
Product Description: Dorset cheese