Recalls That Should Be on Your Radar—Week of July 21, 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:

Bayer Issues Recall of 2 Lots of Kogenate FS Antihemophilic Factor

Bayer is voluntarily recalling two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment, Jivi® antihemophilic factor (recombinant) PEGylated-aucl 3000 IU. The U.S. is the only country where affected products were distributed. We are working closely with the U.S. Food and Drug Administration to manage the recall and to minimize disruption to supply and inconvenience to patients. The affected lots, distributed from February 5, 2019 to July 15, 2019 from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS, are listed below.

Read more about this recall here.

Mountain Rose Herbs Issues Recall of Fennel Seeds Due to Salmonella Risk

Mountain Rose Herbs (MRH) of Eugene, Oregon is recalling all sizes ranging from 4 oz. to 50 lbs. of its Fennel Seed Whole, Lot #25031, because they have the potential to 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 Fennel Seed Whole was sold directly to customers who ordered from mountainroseherbs.com, purchased at the company’s retail shop in Eugene, Oregon, or placed mail orders by phone or fax. The affected product was also distributed to vitamin and health food stores in AZ, CA, CO, FL, IL, MA, MI, MN, MT, NC, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV and to one consignee in Canada. It is possible MRH customers also resold the Fennel Seed Whole to their own clientele.

Read more about this recall here.

Elevation Foods Issues Recall for Products with Listeria Risk

Elevation Foods is voluntarily recalling containers of Archer Farms-brand egg salad; Freskëtbrand egg salad, tuna salad, and Thai lobster salad; and Archer Farms-brand deviled egg sandwiches produced on June 18, 2019 due to possible contamination 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.

We believe fewer than 1,087 cases of product have been directly shipped to retailer warehouses throughout the United States.

No illnesses have been reported to date.

The recalled products were manufactured at Elevation Foods’ Knoxville, Tennessee facility.

Read more about this recall here.

Jubilant Cadista Pharmaceuticals, Inc. Issues Recall of Products Due to Out of Specification Dissolution Test Results

Salisbury, Maryland, Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level. The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point. The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain under contract from Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Drive Salisbury, Maryland 21801.

As a result of the OOS dissolution results, product efficacy may be decreased due to incomplete absorption of the active ingredients. To date, Jubilant Cadista Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Read more about this recall here.

Herbal Doctor Remedies Issues Recall of All Products Due to Marketing Without FDA Approval

Herbal Doctor Remedies is voluntarily recalling all drug products (see table below) within expiry to the consumer level. These products have been marketed without FDA approval and were manufactured outside of the controls required by current Good Manufacturing Practices (cGMP).

These products could potentially result in risk to consumers as they are marketed with intended uses not amendable to self-diagnosis. In addition, lack of controls in the manufacture of the products do not provide assurances of finished product quality. To date, Herbal Doctor Remedies has not received any reports of adverse events related to this recall.

These products are intended to be used as Chinese Herbal Medicines marketed for treatment of disease conditions in humans which the FDA has determined may constitute unapproved new drugs.

Read more about this recall here.

US Foods Issues Recall of Raw Beef and Pork Products Due to Possible Contamination

US Foods, a Birmingham, AL, establishment, is recalling approximately 712 pounds of raw beef and pork products that may be adulterated due to possible product contamination, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The fresh and frozen raw beef and pork items were produced July 18, 2019.

The products subject to recall bear establishment number “EST. 21103” inside the USDA mark of inspection. These items were shipped to restaurants in Alabama, Florida, Georgia, Mississippi and Tennessee.

The problem was discovered after the facility learned that an employee may have cut himself during production.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Read more about this recall here.