Recalls That Should Be on Your Radar—Week of January 20, 2019

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:

Stino Da Napoli Issues Recall for Products Without Benefit of Inspection

Stino Da Napoli, a Rocky River, Ohio establishment, is recalling approximately 11,392 pounds of various meat products that were produced, packed and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat meat products and meat sauce items were produced from Nov. 30, 2017 through Dec. 20, 2018.

The sauce products subject to recall bear establishment number “EST. 45779” inside the USDA mark of inspection. The meatball and lasagna products do not include the USDA mark of inspection. These items were shipped to retail stores in Ohio.

The problem was discovered on Jan. 15, 2019 when an FSIS investigator visited a farmer’s market in Solon, Ohio and observed products produced by Stino Da Napoli being offered for sale.

For a list of affected products, check out the USDA’s announcement.

General Mills Recalls 5-Pound Bags of Flour Potentially Contaminated with Salmonella

General Mills announced today a voluntary national recall of 5-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020.

The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the 5-pound bag product.

This recall is being issued out of an abundance of care as General Mills has not received any direct consumer reports of confirmed illnesses related to this product.

This recall only affects this one date code of Gold Medal Unbleached Flour 5-pound bags.

To learn more about this recall, read the company’s announcement.

Satur Farms Issues Recall for Spinach and Mesclun Potentially Contaminated with Salmonella

Satur Farms of Cutchogue, NY, is voluntarily recalling Baby Spinach and Mesclun because it has the potential to be contaminated with Salmonella.

The voluntary recall is being initiated following routine sampling by Florida Department of Agriculture and New York State Department of Agriculture and markets.

Consumers who have purchase Satur Farms products with these lot numbers are urged to return it to the place of purchase for a full refund.

For lot numbers and additional details, check out the recall statement.RELATED:

In response to a recall by Satur Farms, Whole Foods Market is voluntarily recalling various prepared foods items in eight states containing baby spinach because of potential contamination of Salmonella.

The affected products, including salads, pizza, sandwiches and wraps, were sold at stores in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, New York, and Rhode Island. No illnesses have been reported at this time.

Affected products are labeled with a Whole Foods Market scale label and can be identified by the following information. Additionally, consumers who purchased items containing baby spinach from the salad bars or hot bars at Whole Foods Market locations in these states should discard items purchased through January 23, 2019.

To read the remainder of this statement, visit the FDA's website.

H&T Seafood, Inc. Recalls Silurifomes Products Without Benefit Inspection

H & T Seafood, Inc., the Importer of Record, a Bell, Calif. firm, is recalling approximately 71,435 pounds of imported Siluriformes fish products because the products were not presented for import re-inspection upon entry into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The Siluriformes products were imported from Vietnam to the U.S. on various dates from Nov. 29, 2017 through Oct. 14, 2018. The products have a shelf life of two years.

These items were shipped to retail locations in California, Nevada and Texas.

The problem was discovered by FSIS during a routine surveillance activity at the distributor facility.

There have been no confirmed reports of adverse reactions due to consumption of these products.

For a list of recalled products, check out the USDA’s recall announcement.

Medical Device and Product Recalls:

Torrent Pharmaceuticals Updates Recall of Losartan Potassium and Hydrochlorothiazide Tablets

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-nitrosodiethylamine (NDEA), which 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 as per international Agency for Research on Cancer (IARC) classification. Torrent is only recalling lots of losartan containing products that contain Nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

To learn more about this recall and previous recalls of Losartan tablets, check out the recall announcement.

Draeger Medical Recalls Breathing Circuits and Anesthesia Sets

Draegar Medical is recalling its disposable VentStar and ID Breathing Circuits and Anesthesia Sets due to a risk of the devices being incorrectly assembled, resulting in a short-circuit in the breathing hose. If the breathing hose is short circuited, the patient will not receive the expected breathing support (ventilation). Lack of breathing support may result in irreversible patient harm, up to and including severe oxygen-loss (hypoxia) and death.

Draeger Medical's VentStar and ID Breathing Circuits and Anesthesia Sets are single-use, disposable, accessory devices used with a ventilator or anesthesia machine to provide mechanical ventilation and critical breathing support to infant, child, and adult patients. These devices are designed to be used only under a health care professional's supervision.

For more information about this recall, check out the recall statement.

Statement from FDA On the Ongoing Investigation into Valsartan and ARB Class Impurities

Last summer, the FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards. ARBs, including valsartan, irbesartan, losartan and others, are a class of medicines used to treat high blood pressure and heart failure. Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), are probable human carcinogens. These two substances are known environmental contaminants and found in water and foods, including meats, dairy products and vegetables. But their presence in drug products is not acceptable.

We were deeply concerned when we learned about the presence of these impurities. We immediately undertook a major operation to investigate and to identify the root causes for the presence of these impurities in some ARB drugs, and to work with companies to address the risks that the impurities pose to patients.

To read the full statement, visit the FDA's website.