Tag: Pet Health

Miscellaneous Recalls and Alerts: March 1-24, 2013

Here are some miscellaneous recalls and alerts from around the world. The live links will take you directly to the official notices or company news releases that contain detailed information for each item.

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United States

  • The Ohio Department of Agriculture and the Ohio Department of Health alert consumers to the risk of lead poisoning associated with eye-area cosmetics (e.g., pencils and eyeliners) called Surma (also known as Kohl or Kajal), a powdered eye area product manufactured and used in the Middle East, India, Pakistan and some parts of Africa.
  • The Washington State Department of Agriculture (WSDA) has revoked the food processing license of Chu Minh Corp., which produces tofu and other soy products, after several inspections found on-going sanitation problems with the Seattle business.
  • CDC issues final update for its investigation of a multistate outbreak of Salmonella Typhimurium infections linked to ground beef. The contaminated ground beef was linked to 22 illnesses (including 7 hospitalizations) in six states.
  • CDC is investigating an outbreak of vomiting and diarrhea that sickened 118 passengers and 3 crew members on Royal Caribbean’s Vision of the Seas during a February 25 to March 8, 2013 cruise.
  • CDC is investigating an outbreak of vomiting and diarrhea that sickened 266 passengers and 10 crew members on Princess Cruises’ Ruby Princess during a March 3-10, 2013 cruise.
  • Green Planet, Inc. (Riverside, CA) recalls Night Bullet after FDA finds that the product contains trace amounts of undeclared Sulfohydroxyhomosildenafil and Aminotadalafil.
  • Med Prep Consulting, Inc. (Tinton Falls, NJ) recalls all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold.
  • Clinical Specialties recalls All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance.
  • Cargill’s animal nutriton business recalls certain brands of its ruminant mineral products because they were deficient in vitamins A, D and E.
  • Diamond Pet Foods (Columbia, SC) recalls limited production codes of Premium Edge Finicky Adult Cat Formula dry cat food, Premium Edge Senior Cat Hairball Management Formula dry cat food, Premium Edge Kitten Formula dry cat food, Diamond Naturals Kitten Formula dry cat food and 4health All Life Stages Cat Formula dry cat food. Tests conducted by the company indicated the products might have a low level of thiamine (Vitamin B1).
  • Steve’s Real Foods (Murray, UT) recalls 5 lb. bags of Turducken Canine Diet – 8oz. Patties due to potential contamination of Salmonella.
  • Bravo! recalls 2 lb tubes of Bravo! Raw Food Diet Chicken Blend for Dogs and Cats, product code: 21-102, batch ID code 6 14 12, because it has the potential to be contaminated with Salmonella.
  • Diggin’ Your Dog™ withdraws Strippin’ Chicks™ Pet Treats produced on 8-30-12 because they have the potential to be contaminated with Salmonella.
  • Natura Pet Products recalls specific lots of California Natural, Evo, Healthwise, and Innova dry pet food because it has the potential to be contaminated with Salmonella. The affected products are sold in bags through veterinary clinics, select pet specialty retailers, and online in the United States, Canada, Korea, Malaysia, Japan, Hong Kong, and Costa Rica.
  • Jones Natural Chews Co. (Rockford, IL) recalls 245 boxes of Woofers (beef patties) because it has the potential to be contaminated with Salmonella.
  • Procter & Gamble withdraws certain lot codes of Iams Shakeables Turkey Dog Treats and Iams Shakeables Lamb Dog Treats due to potential for mold growth.

Canada

  • Natura Pet Products recalls specific lots of California Natural, Evo, Healthwise, and Innova dry pet food because it has the potential to be contaminated with Salmonella. The affected products are sold in bags through veterinary clinics, select pet specialty retailers, and online in the United States, Canada, Korea, Malaysia, Japan, Hong Kong, and Costa Rica.

Asia, Africa and the Pacific Islands

  • Natura Pet Products recalls specific lots of California Natural, Evo, Healthwise, and Innova dry pet food because it has the potential to be contaminated with Salmonella. The affected products are sold in bags through veterinary clinics, select pet specialty retailers, and online in the United States, Canada, Korea, Malaysia, Japan, Hong Kong, and Costa Rica.

Australia and New Zealand

  • Australia: The Therapeutic Goods Administration has tested Paiyouji Natural Slimming Capsules and found that it contains the undeclared prescription substance sildenafil and the undeclared substance phenolphthalein which was previously used as an oral laxative, but is no longer available in Australia due to serious safety concerns.
  • Australia: The Victoria Department of Health is investigating a four-fold increase in Cryptosporidium notifications since January 2013. While initially focussed on metropolitan Melbourne, an increase in notifications is now affecting regional Victoria.
  • New Zealand: The Ministry for Primary Industries (MPI) is warning that drought conditions in some parts of the country could lead to higher than usual levels of tutin in honey. Tutin is well known as a natural toxin in honey in some parts of New Zealand.
  • New Zealand: Hawke’s Bay’s water operators are checking the region’s supplies for contamination of Cryptosporidium. The New Zealand Herald reports that 45 people have been diagnosed with the parasite over the past two months.

Latin America and the Caribbean

  • Natura Pet Products recalls specific lots of California Natural, Evo, Healthwise, and Innova dry pet food because it has the potential to be contaminated with Salmonella. The affected products are sold in bags through veterinary clinics, select pet specialty retailers, and online in the United States, Canada, Korea, Malaysia, Japan, Hong Kong, and Costa Rica.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall website.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

FDA Bares Teeth. Kasel Flinches.

In case anyone hasn’t yet figured it out, the Mandatory Recall Authority that Congress granted FDA under the Food Safety Modernization Act was responsible for Kasel’s ‘voluntary’ recall of Salmonella-contaminated pet treats.

Earlier today, FDA released the letter in which the agency threw down its gauntlet and demanded that Kasel Associates Industries, Inc. recall contaminated pet treats. The  February 13, 2013 “Notification of Opportunity to Initiate a Voluntary Recall”, was hand-delivered to Raymond J. Kasel. The letter stated the basis for FDA’s determination that “…there is a reasonable probability that the affected pet treats are adulterated under section 402(a)(1) and (a)(4) of the FD&C Act and that there is a reasonable probability that the use of or exposure to the pet treats will cause serious adverse health consequences or death to humans or animals…” A sampling of the findings include:

  • Multiple finished product samples of Kasel pet treats obtained by the State of Colorado’s Department of Agriculture in September and October 2012, were tested and subsequently found to be positive for Salmonella.
  • In response to the state of Colorado’s Salmonella-positive results, FDA conducted an inspection of Kasel’s manufacturing facility from September 19-28, 2012. During the inspection, the FDA investigators collected various samples for further testing, including bulk and finished product samples and numerous environmental samples. Many of these samples tested positive for Salmonella.
  • Salmonella is a pathogenic organism that can cause serious adverse health consequences or death in humans and animals. The presence of Salmonella in pet food can pose a particularly acute health risk to children and people who are elderly or immunocompromised.
  • [E]vidence collected by FDA and the state of Colorado, including environmental and product samples collected and analyzed by Colorado and the FDA, and observations made by FDA during the inspection of [Kasel], establishes the following:
    • Pet treat products manufactured, processed, packed, or held by [Kasel] from April 20, 2012, through September 19, 2012, are contaminated with Salmonella, or are at risk for contamination with Salmonella, based on the conditions in your facility and multiple Salmonella-positive results from environmental samples, including positive results on food contact surfaces within your facility, and from samples of your finished product. Test results indicate there are more than a dozen different Salmonella serotypes in your firm’s manufacturing facility and finished products. In addition, the test results indicate that various Salmonella positive samples from finished products are serotype matches to, and in some cases share a Pulsed Field Gel Electrophoresis (PFGE) pattern with, other finished products and/or various environmental swabs taken at the facility during the September 2012 inspection. Due to this widespread Salmonella contamination and/or risk of contamination, FDA has determined that there is a reasonable probability these products are adulterated under section 402 of the FD&C Act and there is a reasonable probability that the use of or exposure to these pet treats will cause serious adverse health consequences or death to humans or animals.
    • [Kasel] created, caused or was otherwise responsible for this reasonable probability of adulteration: under section 402 of the FD&C Act. Specifically, FDA has determined that the conditions within your facility (e.g., the presence of Salmonella in various locations throughout the facility and multiple sanitation deficiencies) that could lead to cross contamination between raw materials and finished products caused the reasonable probability.”

The letter, which was signed by Michael R. Taylor (FDA’s Deputy Commissioner for Foods and Veterinary Medicine), demanded action within two (2) business days of its receipt by Mr. Kasel, and concluded with the following two statements:

“If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats. Additionally, FDA may, by order require you to immediately notify all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling the affected pet treats to immediately cease distribution of such articles; and to immediately notify all persons to which such articles have been distributed, transported, or sold, to immediately cease distribution of the affected pet treats.”

“If a response is not received from you within two (2) business days of your receipt of this letter, FDA may by order require you to immediately cease distribution and notify applicable parties, as explained above.” 

The food and pet food industries are now on notice. FDA is ready, willing and able to use its mandatory recall authority to achieve the removal of dangerously contaminated food and pet food from the marketplace.

Kasel Inspection Report: Roaches and Rodents and Filth. Oh My!

FDA has released its Inspectional Observations report (Form 483) covering the issues encountered during the agency’s September 19 – 28, 2012 inspection of the Kasel Associates Industries, Inc. manufacturing plant in Denver.

Last week, Kasel recalled a range of pet treats manufactured from April 20, 2012 through September 19, 2012 due to potential Salmonella contamination. As I reported yesterday, FDA found 14 different Salmonella strains in finished product and environmental swab samples taken at the company’s manufacturing facility during the September 2012 inspection.

FDA’s 9-page report documents improper sanitation throughout the facility, inadequate pest control – including live and dead cockroaches, rodent droppings, flies and a dead mouse – improper food storage, improper handling of work-in-progress, and inadequate maintenance. Following is just a sampling of the deficiencies:

OBSERVATION 1. Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food–contact surfaces, and food-packaging materials.

  • Food debris build-up on and underneath conveyor belts on packing lines
  • Food and grease build-up on metal crates used to hold finished product before packaging
  • Finished, unpackaged bulk product stored in grease-laden and reused cardboard totes
  • Floor fan with accumulated dust and grease was blowing onto uncovered bulk bins of unpackaged finished product

OBSERVATION 2. Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

  • Larvae-like inspects on floor drain of Cutting Room
  • Live and dead cockroaches in numerous areas, including the Packaging Room, Bulk Storage Room and Preparation Room
  • Large flies (live and dead) in the Packaging Room
  • Dead mouse in Bulk Storage Room partially under pallet of finished product
  • Rodent excreta pellets in the General Storage Room near pallets of finished/packaged products

OBSERVATION 3. Failure to take effective measures to protect against the inclusion of metal and extraneous material in food.

  • No functioning metal detector on packaging lines
  • Wooden pallets with chipping wood and loose nails stored directly on top of uncovered bulk bins of finished product
  • Metal fragments in direct contact with chicken chips on drying racks

OBSERVATION 4. Failure to take effective measures to protect finished food from contamination by raw materials.

  • Plastic tubs used in both raw production and finished product packaging to hold both raw and finished product; no system in place to differentiate which tubs were used for which purpose
  • No dedicated washing equipment or system to wash, rinse and sanitize the plastic tubs

OBSERVATION 5. Failure to store finished food under conditions that would protect against physical and microbial contamination.

  • Finished product stored uncovered in bulk bins
  • Finished product stored in unlined wire bulk crates in direct contact with floor

OBSERVATION 6. Failure to handle work-in-progress in a manner that protects against contamination.

  • Uncovered pallet of frozen chicken stored on loading dock while employees loaded a truck with loading dock door open
  • Floor sanitizer foam sprayer (label states chemical unfit for human or pet consumption) observed spraying onto uncovered bulk pallet of frozen chicken chips

OBSERVATION 7. Failure to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated.

  • Floors not sealed: grease accumulation in cracks and exposed concrete, visible chipping paint
  • Broken, taped and swollen ceiling tiles above filling lines and throughout Packaging Room
  • Broken and missing light shields
  • Hand sinks in Preparation Room not functioning

OBSERVATION 8. Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.

  • Employees observed not washing hands after leaving rest room or break room

Is it any wonder that Salmonella ran rampant throughout this facility?