Recalls That You Should Be Aware of—Week of December 2, 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:

JBS Tolleson, Inc. Expands Recall of Beef Potentially Contaminated with Salmonella Newport

This recall includes an additional 5,156,076 pounds of raw beef products. In total 12,093,271 pounds of non-intact raw beef products have been recalled by JBS Tolleson, Inc.

After FSIS Recall 085-2018 on October 4, 2018, FSIS, CDC, and state public health and agriculture partners continued to investigate the outbreak of Salmonella Newport illnesses. The epidemiological investigation has identified 246 confirmed case-patients from 25 states with illness onset dates ranging from August 5, 2018 to October 16, 2018.

An additional 16 case-patients have provided receipts or shopper card numbers for the product traceback investigations. Specific traceback for three case-patients have identified JBS Tolleson, Inc., EST. 267 ground beef products that were not part of the October 4, 2018 recall. FSIS will continue to work with public health partners and provide updated information should it become available.

The raw, non-intact beef items, including ground beef, were packaged on various dates from July 26, 2018 to Sept. 7, 2018.

To learn more about this recall, consult the USDA’s statement.

Columbia River Natural Pet Food Inc. Issues Recall for Potential Listeria Monoctyogenes Contamination

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes.

Listeria monocytogenes may affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not washed their hands after having contact with the products or any surfaces exposed to this product.

Cow Pie was distributed in Alaska, Oregon, and Washington through retail stores and direct delivery. The product comes frozen in 2 lbs. purple and white plastic bags, with Lot 81917 (processed on August 19, 2017) found on an orange sticker.

No illnesses have been reported to date.

The potential for contamination was noted after routine testing by the Washington State Department of Agriculture revealed the presence of Listeria monocytogenes in one package.

To learn more about the risk to humans, check out the recall statement.

Medical Device Recalls:

Mylan Expands Recall of Valsartan Tablets due to Presence of Impurities

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).

Out of an abundance of caution, 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).

For a complete list of recalled products, consult the company’s statement.

Trip Pharma Recalls Infants’ Ibuprofen Products Due to Potential of Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury.

Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.

To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.

For a list of affected products, read the recall statement.

FDA Warnings & Statements:

FDA Alerts Consumers to Possible Hepatitis A Contamination of Bauer’s Candies Modjeskas

The FDA is alerting consumers to possible hepatitis A contamination of Bauer’s Candies Modjeskas, an individually wrapped marshmallow candy dipped in chocolate or caramel. We are advising consumers not to eat and to throw away any Bauer’s Candies Chocolate or Caramel Modjeskas, purchased after November 14, 2018 because a worker in the facility tested positive for hepatitis A.

These products are available at retail locations and can also be purchased through QVC and BauersCandy.com. We are currently working with Bauer’s Candies, located in Kentucky, on a voluntary recall of affected products. This posting will be updated with recall and retail information as it becomes available.

At this time, the FDA and the Centers for Disease Control and Prevention (CDC) are not aware of any cases of hepatitis A related to consumption of these candies. Hepatitis A can have a long incubation period and can have serious health consequences for some people, especially those with other health problems.

Although the risk of hepatitis A transmission from the candy is low, FDA recommends that consumers who ate candies purchased after November 14, 2018 and have not been vaccinated for hepatitis A consult with their healthcare professional to determine whether post exposure prophylaxis (PEP) is indicated. PEP may be recommended for unvaccinated people who have been exposed to hepatitis A virus (HAV) in the last 2 weeks; those with evidence of previous hepatitis A vaccination do not require PEP.

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

FDA Warns Health Care Professionals to Not Use Promise Pharmacy Products

The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, Florida, 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.



During FDA’s recent inspection of Promise Pharmacy’s facility, investigators observed insanitary conditions, including poor sterile production practices and inadequate design of one of its processing rooms, which raised concerns about the company’s ability to assure the sterility of its drug products from that processing room.



Examples of products compounded in this room include bremelanotide, sermorelin, BPC-157, arginine HCL, leucine/isoleucine/valine, dexapanthenol and/or ascorbic acid. There may be additional drug products that were compounded in that processing room.

For all information regarding this FDA warning, consult the FDA’s advice.