Recalls You Should Be Aware Of—Week of October 28, 2018

We’ve rounded up a list of important US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) recalls from this past week.

Aurobindo Pharma Limited Issues Recall of Irbesartan due to Trace Amounts of NDEA

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

These 22 batches of Irbesartan drug substance were supplied to ScieGen Pharmaceuticals Inc., U.S. for the manufacturing of finished Irbesartan drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program.

For a list of recalled batches, consult the company’s announcement.

Scigen Pharmaceuticals, Inc. Issues Recall of Irbesartan Tablets due to Trace Amounts of NDEA

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

Irbesartan tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg were manufactured by ScieGen Pharmaceuticals Inc and are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc [GSMS].

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

Roche Diagnostics Recalls CoaguChek XS PT Strips Due to Inaccurate Test Results

Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT Test Strips in January 2018 to correspond to a newly released INR International Standard. Since this re-calibration, Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with the affected CoaguChek XS PT Test Strips listed in the table below.

Use of affected products may increase the risk of serious adverse health consequences, including death.

To read more about this recall, visit the FDA’s MedWatch website.

Procesadora La Hacienda, Inc. Issues Recall for Beef Products Potentially Contaminated with Foreign Matter

Procesadora La Hacienda, Inc., a San Lorenzo, P.R. establishment, is recalling approximately 2,400 pounds of ready-to-eat (RTE) corned beef products that may be contaminated with extraneous materials, specifically soft plastic and metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced.

The RTE corned beef items were produced on October 4, 2018. The products subject to recall bear establishment number “EST. 21217A” inside the USDA mark of inspection. These items were shipped to institutions in Puerto Rico.

FSIS has received no reports of injury or illness from consumption of these products.

For more information on this recall, check out the USDA’s statement.

Les Aliments O Sole Mio, Inc. Issues Recall for Products Produced Without Benefit of Inspection

Les Aliments O Sole Mio, Inc., a Boisbriand, Quebec, Canada establishment, is recalling approximately 3,880 pounds of chicken tortellini products that were produced without the benefit of inspection by the Canadian Food Inspection Agency (CFIA) and imported into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced.

The heat treated, not fully cooked, not shelf stable chicken tortellini items were produced on October 20, 2018.

The products subject to recall bear Canadian establishment number “764” within the Canadian mark of inspection. These items were shipped to warehouse locations in Florida, Illinois, Maryland, Massachusetts, and Pennsylvania.

The problem was discovered when the CFIA notified FSIS that the Canadian establishment produced the product outside the approved period of work shift agreement.

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

To learn more about this class I recall, consult the news release.

Suzanna’s Kitchen, Inc. Issues Recall for Poultry Products Due to an Unapproved Substance

Suzanna’s Kitchen, Inc., a Peachtree Corners, Ga. establishment, is recalling approximately 15,408 pounds of grilled chicken products due to an unapproved substance, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced. The product contains concentrations of thallium.

The ready-to-eat (RTE) grilled chicken strip items were produced on June 20, 2018.

The problem was discovered when the Michigan Department of Health and Human Services tested retail packages of Nature Raised Farms Organic Gluten Free Grilled Chicken Strips produced by Suzanna’s Kitchen, Inc. and found concentrations of thallium in the product.

The concentration levels do not present an immediate health hazard; however, FSIS is recommending this Class II recall out of an abundance of caution because prolonged ingestion of contaminated product in sensitive populations could cause some health effects. FSIS is working with the involved parties to identify the source of the contamination and prevent any further product from going into commerce.

For more information on this recall, read the USDA’s statement.

J&J Snack Foods Handheld Corp., Issues Recall of Fit & Active Southwest Sandwiches Due to Possible Ingredient Contamination with Listeria Monocytogenes and Salmonella

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella.

The Fit & Active Southwest Veggie Stuffed Sandwiches products affected have production dates of Julian code: 20027230003106:15 BEST BY FEB 09 2019 and Julian code: 20027235003115:13 BEST BY FEB 14 2019.

The potential for contamination was discovered after a supplier, McCain Foods, IL, announced it was recalling frozen vegetables which are ingredients used in the product.

Products were distributed between 08/22/2017 - 09/20/2017 to Aldi retail stores in several states.

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