Recalls That Should Be On Your Radar — Week of January 6, 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:

Hy-Vee Recalls Cheesecakes Due to Potential Salmonella Contamination

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its cheesecakes made with Diamond Crystal Brands cheesecake mix due to the potential that they may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention today after receiving a letter from the supplier. The voluntary recall includes 32 varieties of cheesecakes in both 8-ounce and 32-ounce packages with best if used by dates of Dec. 6, 2018, through Jan. 11, 2019. No illnesses have been reported to date.

The mixture was distributed to 117 of Hy-Vee’s 249 grocery stores across its eight-state region of Iowa, Illinois, Missouri, Kansas, Nebraska, South Dakota, Minnesota and Wisconsin. The product comes in a plastic container with a plastic lid. The expiration date range is between Dec. 6, 2018, and Jan. 11, 2019. The expiration date can be found on the label.

Learn more about this recall by reading the news release.

Grand Strand Sandwich Company Recalls Lunch Box Sandwiches Due to Potential Listeria Monocytogenes Contamination

Grand Strand Sandwich is recalling Lunch Box Italian Subs, Lunch Box Ham & Swiss Croissants and Lunch Box Ham & Cheese Frozen Wedges due to a potential contamination of Listeria monocytogenes. Listeria monocytogenes, 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, a Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

On January 3, 2019 the firm was notified by FDA that the swabs they collected from the meat slicing area on December 11, 2018 test positive for Listeria monocytogenes.

No illnesses have been reported to date.

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

J.H. Routh Packing Co. Recalls Pork Sausage Due to Possible Foreign Matter Contamination

J. H. Routh Packing Co., a Sandusky, Ohio establishment, is recalling approximately 1,719 pounds of raw pork sausage products that may be contaminated with extraneous materials, specifically rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw ground pork bulk and link sausage items were produced from Jan. 1 through 4, 2019.

The products subject to recall bear establishment number “EST. 818” inside the USDA mark of inspection. These items were shipped to retail locations in Kentucky, Ohio and Pennsylvania.

The firm discovered the problem and notified FSIS on Jan. 7, 2019.

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

For a list of affected products, consult the USDA’s press release.

Medical Device and Product Recalls:

Lupin Pharmaceuticals Inc. Recalls Ceftriaxone for Injection Due to Grey Particulate Matter

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

Improper piercing and use of a needle greater than 21 gauge (larger internal diameter), while reconstituting the vial, can push rubber flecks into the solution. There were no grey flecks seen prior to the reconstitution of the vials and the issue was identified upon standard visual inspection prior to patient administration.

If injected, this product (containing rubber particulate matter from the stopper) could cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment of body function or damage to body structures, such as the lungs and vascular system. In addition, as ceftriaxone can be administered intramuscularly, the use of the product may result in local muscle inflammation and/or abscesses.

For more information on this recall, check out the press release.

Sun Pharmaceutical Industries Recalls Vecuronium Bromide for Injection Due to Presence of Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, SPII has not received any reports of adverse events related to this recall.

Vecuronium Bromide for Injection is used as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is packaged in a glass vial; ten vials per carton. Vecuronium Bromide for Injection should be administered by or under the supervision of experienced clinicians and must be reconstituted prior to use.

Learn more about this recall by reading the company’s statement.

Happy Together Inc. Recalls Product Due to Undeclared Sildenafil and Tadalafil

Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.

Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. To date, Happy Together Inc. has not received any reports of adverse events related to this recall.

The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 30 count box. Rhino 5k was distributed to consumers nationwide via the Internet. We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product. Happy Together, Inc. is notifying its customers that have the Rhino 5k products to stop use and properly discard the product.

Learn more about this unapproved drug by checking out the recall statement.

Medtronic Recalls Synergy Cranial Software Due to Inaccuracies Displayed During Surgery

Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm.

During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

For more information on this recall, read the FDA MedWatch statement.