Recalls That Should Be On Your Radar—Week of November 18, 2018

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Food Safety Recalls:

Majestic Meat Company Issues Recall for Beef Products Due to Possible E coli Contamination

Majestic Meat Company, a Salt Lake City, Utah establishment, is recalling approximately 532 pounds of ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The bulk ground beef, ground beef patties, and meatballs were produced on November 8, 2018.

The products subject to recall bear establishment number “EST. 19915” inside the USDA mark of inspection. These items were shipped to restaurants in the state of Utah.

The problem was discovered on November 15, 2018 when FSIS identified that product associated with a sample that confirmed positive for E. coli O157:H7 had been shipped. The establishment held 2 of the 3 boxes of source material associated with the sampled product, however, the third box of source material was further processed and shipped. There have been no confirmed reports of adverse reactions due to consumption of these products.

To read more information about this recall, check out the press release.

Swift Beef Company Issues Recall for Beef Products Due to Possible E coli Contamination

Swift Beef Co., a Hyrum, Utah establishment, is recalling approximately 99,260 pounds of raw non-intact ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The bulk ground beef was produced on Oct. 24, 2018.

The products subject to recall bear establishment number “EST. 628” inside the USDA mark of inspection. These items were shipped to retail distributors for further processing and food service distributors for institutional use in locations in California, Nevada, Oregon, Utah, and Washington.

The problem was discovered on November 15, 2018, when FSIS visited Swift Beef Company in response to a FSIS ground beef sample that was collected at a further processing establishment and was confirmed positive for E. coli O157:H7. FSIS confirmed that Swift Beef Company was the sole source supplier for the ground beef products. That affected product was recalled on Nov. 16 and information on that recall can be found here. There have been no confirmed reports of adverse reactions due to consumption of these products.

For a full list of products affected by this recall, check out the recall statement.

Green Cedar Daily Issues Recall for Ackawai Cheese Due to Presence of Listeria Monocytogenes

Routine samples of the Green Cedar Ackawi cheese collected and tested by the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes.

The following product has been recalled:

Green Cedar Ackawi cheese in small clear plastic shrink wrapped packaging (see images below) bearing a “sell by” date of March 26, 2019 or later. The “sell by” date is on a white sticker on the back of the product.

This issue was discovered on November 9, 2018 during a routine inspection by the Michigan Department of Agriculture & Rural Development, Food & Dairy Division (MDARD) and by the Federal Food and Drug Administration (FDA).

This product was distributed at retail locations East Dearborn and Dearborn Heights Michigan. There have been no reports of adverse health impacts or reactions related to the consumption of this product to date.

To read more about this recall, check out the company’s statement.

Long Phung Food Products Issues Recall for Pork Products Potentially Contaminated with Listeria Monocytogenes

165368 C. Corporation, doing business as Long Phung Food Products, a Houston, Texas establishment, is recalling an undetermined amount of ready-to-eat pork products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat pork patty rolls were produced on various dates from May 21, 2018 through Nov. 16, 2018.

The products subject to recall bear establishment number “EST. 13561” inside the USDA mark of inspection. These items were shipped to distributors and retail locations nationwide.

On October 22, 2018, FSIS was notified of a cluster of listeriosis illnesses that were closely related. Working in conjunction with the Centers for Disease Control and Prevention and state public health partners, FSIS determined that there is a link between the Listeria monocytogenes illnesses and ready-to-eat pork products produced by Long Phung Foods. The epidemiologic investigation identified a total of four listeriosis confirmed illnesses between July 1, 2017 and October 24, 2018. On November 19, 2018, whole genome sequencing of investigative samples collected from Long Phung Foods Establishment M13561 showed that the samples were closely related genetically to Listeria monocytogenes from ill people. FSIS is continuing to work with federal and state public health partners to determine if there are additional illnesses linked to these products and will provide updated information should it become available.

For additional details regarding this recall, read the USDA's statement.

The Quaker Oats Company Issues Recall for 21 Boxes of Cap’n Crunch’s Peanut Butter Cereal

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.

The product being recalled was distributed in limited quantities only to 5 Target stores. This recall only includes 21 outstanding boxes purchased after Nov 5:

To read more about this recall, consult the recall announcement.

Medical Device Recalls

Mylan Issues Recall of Valsartan-Based Tablets Due to Detection of NDEA Impurity

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).

The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed in the U.S. between March 2017 and November 2018.

To read more about this recall, check out the company's statement.

Beckman Coulter Life Sciences Recalls FC 500 Due to Risk of Incorrect Results

Beckman Coulter Life Sciences is recalling the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers due to an electrical circuit error that may cause the device's amplifier board to malfunction and produce inaccurate results. This issue has the potential to impact all tests run on the cytometers for any application, including laboratory-developed tests.

The FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. These devices can be used to diagnose and monitor conditions, like blood cancers, and other blood disorders, and for immune monitoring in HIV patients and other immunocompromised patients.

The FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers are also used to count white blood cells in leukocyte-reduced blood products and to count CD34+ stem cells for FDA licensed cord blood products and other cellular products intended for stem cell transplantation.

No patient injuries have been reported to date, however the use of affected product may cause serious, life-threatening adverse health consequences such as misdiagnosis and improper patient management and treatment for several blood conditions and diseases.

For additional details, check out the recall statement.

FDA Warnings & MedWatch Alerts:

FDA Reminds Clinicians to Not Use Products Produced by Pharm D Solutions

The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions LLC, Houston, Texas, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

Health care professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Health care professionals should also make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.

FDA issued a warning letter to Pharm D in December 2016 following an inspection. During FDA’s recent follow-up inspection of Pharm D’s compounding facility in August 2018, investigators observed unsanitary conditions, including poor sterile production practices and deficient environmental monitoring. These conditions raised concerns about the company’s ability to assure the sterility of its drug products.

On September 10, 2018, following FDA’s recommendation, Pharm D recalled all unexpired drug products intended to be sterile and agreed to cease sterile operations until it makes adequate corrections at its facility. However, Pharm D resumed sterile operations on October 8, 2018, and distributed purportedly sterile products without making adequate corrections at the facility. Pharm D agreed to cease sterile operations again on November 9, 2018, but has not agreed to FDA’s recommendation to recall all unexpired drug products intended to be sterile. These compounded drug products could put patients at risk.

For more information, consult the FDA’s statement on this matter.

FDA Warns of Severe Worsening of Multiple Sclerosis After Stopping Fingolimod

FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.

Healthcare professionals should:

• Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.
• Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.
• Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.
• Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.
• Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.

To read the FDA’s recommendations, check out the MedWatch alert.