Recalls That Should Be On Your Radar— Week of November 25, 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:

Achdut Recalls Tahini Products Linked to Salmonella Outbreak

Achdut LTD. of Ariel, Israel, is recalling its Tahini products of all packages and sizes produced on the following dates: April 7th to May 21st 2018, because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled "Tahini" was distributed internationally in retail stores and through mail orders.

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

Sprout Creek Farm Recalls Cheese Due to Potential Listeria Monocytogenes Contamination

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has 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. Although 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.

No illnesses have been reported to date. Any consumer with the product should dispose of it immediately. Sprout Creek Farm has been in contact with distributors and markets to immediately remove this batch of "Kinkead" cheese from their shelves.

For more information on these products, check out the recall statement.

Medical Device Recalls:

Fresenius Kabi Recalls Sodium Chloride Injection Due to Incorrect Product Labels

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.

Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. It is also indicated for use in flushing of intravenous catheters. The product is packaged as Sodium Chloride Injection, USP 0.9%, 10mL fill in a 10mL vial; Sodium Chloride Injection, USP 0.9% 20mL fill in a 20mL vial; both size vials are packaged in a 25-unit tray.

For more information on this device recall, consult the news release.

Pfizer Inc. Recalls 6 Lots of Thermacare Heat Wraps Due to Leaks

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

The use of a leaking/damaged heat cell wrap could cause skin injuries such as burns/blisters and/or skin irritation on the wrap applied area. The product label warns not to use the product if heat cell contents leak and/or the wrap is damaged or torn.

These lots were distributed nationwide to retailers, wholesalers and distributors in the United States, Puerto Rico and the U.S. Virgin Islands from September 2017 through August 2018.

For additional information about this recall, consult the press release.

Zimmer Biomet, Inc. Recalls Spinal Fusion and Long Bone Stimulators

Zimmer Biomet, Inc. is recalling the EBI Osteogen Implantable Bone Growth Stimulator, SpF® PLUS-Mini (60 μA/W) Implantable Spinal Fusion Stimulator, and the SpF®-XL IIb 2/DM Implantable Spinal Fusion Stimulator due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.

The lack of adequate validation and controls may or may not cause serious side effects for the patient including infection, tissue death, additional surgery for wound treatment and/or device removal, impaired wound and bone healing, the need for long-term antibiotic therapy, the potential for secondary gastroenteritis, swelling and infection around the spinal cord (epidural abscess), paralysis, damage to other organs or death.

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

Teva Pharmaceuticals Recalls All Amlodipine/Valsartan & Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.

Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure. To date, Teva has not received any reports of adverse events signaling a potential link or exposure to valsartan.

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

FDA Warnings & Statements:

FDA Warns Consumers to Avoid Rhino Products for Male Enhancement Due to Dangerous Ingredients The U.S. Food and Drug Administration is warning consumers not to purchase or use Rhino male enhancement products, due to a recent rise in reported health issues. Since 2007, the FDA has identified more than 25 products marketed with variations of the name “Rhino” that contained hidden drug ingredient(s).

These products continue to be sold at gas stations and convenience stores, as well as on websites such as eBay and Amazon. More recently, these unapproved products have been discovered in international mail shipments to the U.S. These products are often sold in single-serving package sizes. Rhino products include names such as Platinum Rhino 25000, Krazzy Rhino 25000 and Gold Rhino 25000.

The FDA has received reports of people experiencing chest pain, severe headaches and prolonged erections after taking a Rhino product that led to surgical intervention and hospitalization due to extreme drops in blood pressure.

For more information read the Rhino male enhancement products, the news release.

FDA Commissioner Scott Gottlieb, MD, Issues Statement on Metals Found in Kratom Products

Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms. These include warnings about the contamination of kratom products with extremely high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls and the agency’s first-ever mandatory recall order after a rigorous investigation. As part of our efforts to assess kratom for contamination in the products tested, we also found disturbingly high levels of heavy metals in kratom products.

As a result of our analysis, we’re contacting companies marketing these kratom products to make them aware of the heavy metal testing results. And we are putting out this advisory to warn consumers so that they can take steps to protect their health.

To read more about the kratom findings, check out Dr. Gottlieb’s letter.

FDA Warns of Serious Risks Associated with Multiple Sclerosis Drug Lemtrada

The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. We have also added the risk of stroke to the existing Boxed Warning, FDA’s most prominent warning.

Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 to treat a type of cancer called B-cell chronic lymphocytic leukemia (B-CLL).

The Campath drug label will also be updated to include these risks in the Adverse Reactions section under Postmarketing Experience.

Patients or their caregivers should seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection, which can include: Sudden numbness or weakness in the face, arms, or legs, especially if it occurs on only one side of the body Sudden confusion, trouble speaking, or difficulty understanding speech Sudden trouble seeing in one or both eyes Sudden trouble with walking, dizziness, or loss of balance or coordination Sudden severe headache or neck pain

For more information, read the FDA’s statement.

FDA Drug Safety Communication on Idhifa

The U.S. Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. However, we have become aware of cases of differentiation syndrome not being recognized and patients not receiving the necessary treatment.

As a result, we are alerting health care professionals and patients about the need for early recognition and aggressive management of differentiation syndrome to lessen the likelihood of serious illness and death. We are continuing to monitor this safety concern.

Health care professionals should describe to patients the symptoms of differentiation syndrome listed in the Medication Guide when starting Idhifa and at follow-up visits, and inform them to call their health care professional if such symptoms occur. Differentiation syndrome has occurred as early as 10 days and up to 5 months after starting the medicine. If patients experience unexplained respiratory distress or other symptoms, consider a diagnosis of differentiation syndrome and treat promptly with oral or intravenous corticosteroids (See Additional Information for Health Care Professionals).

To read the full communication, consult the statement.