Recalls You Should Be Aware Of—Week of November 11, 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:

Alebrije Dist Wholesale Recalls Cheese Products Due to Positive Salmonella Sample

Alebrije Dist Wholesale is collaborating with health officials due to a positive detection of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. Alebrije Dist Wholesale is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, Alebrije Dist Wholesale has decided to voluntarily recall the specific “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

Affected product was distributed the dates between October 23 and October 24 through retail sale and direct delivery, in Los Angeles, CA.

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

Jennie-O Turkey Store Sales, LLC Recalls Raw Ground Turkey Products due to Possible Salmonella Contamination

Jennie-O Turkey Store Sales, LLC, a Barron, Wis. establishment, is recalling approximately 91,388 pounds of raw ground turkey products that may be associated with an illness outbreak of Salmonella Reading, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw ground turkey products items were produced on September 11, 2018.

The products subject to recall bear establishment number “P-190” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

FSIS, and its public health partners, including the Centers for Disease Control and Prevention (CDC) and the Arizona Department of Health Services, have been conducting traceback activities for a sample of Jennie-O brand ground turkey in an intact, unopened package from a case-patient’s home. The patient tested positive for Salmonella Reading and the sample from the ground turkey matches the outbreak strain.

FSIS, the CDC, and state public health and agriculture partners, have been working together on an illness cluster involving 164 case-patients in 35 states. Patients have reported eating different types and brands of turkey products purchased from many different stores, handling raw turkey pet food and/or raw turkey, or working with live turkeys or living with someone who handled live turkeys. FSIS continues to work with the CDC and state health departments on this investigation and will provide updated information as it becomes available. Based on the continuing investigation, additional product from other companies may also be recalled.

To read more about the Salmonella Reading outbreak linked to turkey products, check out our coverage and to see if your state is affected, consult the Outbreak Monitor.

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

The Pictsweet Company Issues Recall for 8-Ounce Steam’ables Asparagus Spears due to Listeria Monocytogenes

The Pictsweet Company has recalled 1,872 cases of Pictsweet Farms 8-ounce Steam’ables Asparagus Spears because they have the potential to be contaminated with Listeria monocytogenes.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recall affects only Pictsweet Farms 8-ounce Steam’ables Asparagus Spears identified by UPC code 0 70560 97799 9 with production codes beginning with the following six digits: 2138XD and a “BEST BY AUG 1, 2020.”

No illnesses have been reported to date and no other Pictsweet Farms products are impacted by this recall.

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

Ron’s Home Style Foods Recalls Chicken Salad Products due to Possible Listeria Contamination

Ron’s Home Style Foods, a Houston, Texas establishment, is recalling approximately 6,912 pounds of ready-to-eat (RTE) chicken salad products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The RTE chicken salad items were produced and packaged on October 22, 2018.

The products subject to recall bear establishment number “P-32049” inside the USDA mark of inspection. These items were shipped to institutional and retail locations in Texas.

The problem was discovered on November 13, 2018 during routine record review by FSIS inspection program personnel.

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

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

Medical Device Recalls:

Oscor Inc. Issues Recalls for Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor Inc. is voluntarily taking this action.

In the last six years, a total of four serious injuries were reported to Oscor which were attributed to the above connector cap malfunction. No deaths were reported; however the risk for serious injury and/or death is a concern if the connectors separates during use.

For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required.

For the complete list of product model numbers affected by this recall, consult the official announcement.

Sandoz Inc. Issues Recall of 1 Lot of Potassium and Hydrochlorothiazide Due to Impurities

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. 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).

To date, Sandoz Inc. has not received any reports of adverse events related to this lot.

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

GE Healthcare Recalls Millennium Nuclear Medicine Systems Due to Detector Malfunction

GE Healthcare is recalling the Millennium Nuclear Medicine Systems due to an incident in which the top detector detached and fell onto the detector below it. GE Healthcare has determined that the incident was caused by an improperly functioning primary motion stopper and a missing mechanical stopper which would limit the detector’s travel beyond its limits during normal operation.

GE Healthcare’s Millennium MG, Millennium MC, and Millennium MYOSIGHT Nuclear Medicine Systems are devices used to take images of a patient’s organs (for example, the heart, lungs, or brain) or tissues to help diagnose or treat a health condition or disease. These systems are intended for use as diagnostic imaging devices which allow the user to acquire data for high-resolution, three-dimensional images.

No patient injuries have been reported, although there remains a risk of potential life-threatening bodily harm if the detector were to detach and fall during a patient exam.

For more information about this medical device recall, check out the announcement.

FDA Warnings & MedWatch Alerts:

FDA Issues Warning to StemGenex Biologic Laboratories for Illegally Marketing Unapproved Products in a Facility with Manufacturing Violations

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.

The FDA recently inspected the StemGenex facility and found the company was processing adipose tissue (body fat) into stromal vascular fraction (SVF, a cellular product derived from body fat) for administration in a variety of ways, including intravenously, by inhalation, and directly into the spinal canal. StemGenex illegally markets the SVF product to treat a variety of serious diseases and life-threatening conditions, including Alzheimer’s disease, Crohn’s disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, peripheral neuropathy and rheumatoid arthritis. StemGenex’s SVF product, which involves more than minimal manipulation of a patient’s adipose tissue, is regulated as both a drug and biological product. To lawfully market its SVF product, a valid biologics license must be in effect. While in the development stage, the firm’s SVF product may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or approvals exist for StemGenex’s product, and the firm does not have an IND in effect.

During the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice requirements in the manufacture of the SVF product; including unvalidated manufacturing processes, an uncontrolled environment, lack of control over the components used in production, and the lack of sufficient and validated product testing.

The FDA has requested a response from StemGenex, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction, or prosecution.

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

FDA Advises Caution When Selecting Pain Medicine for Intrathecal Administration

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. While individual patients may experience some relief from using pain medicines not approved for intrathecal administration in their implanted pumps, such use may create additional risks including dosing errors, pump failures, and other safety concerns.

The FDA wants to ensure that patients, caregivers, compounders, pharmacists, and health care providers are aware of these risks to make informed treatment decisions.

The FDA-approved implanted pump labeling identifies which pain medicines are approved for use with each pump. Pain medicines approved by FDA for delivery into the spinal fluid must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses. The implanted pump’s current labeling should be reviewed to determine which pain medicines are approved for use in each pump. The table below includes examples of medicines approved and not approved for intrathecal use with implanted pumps to treat or manage pain.

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