Recalls That Should Be On Your Radar—Week of November 4, 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.

Janssen Issues Recall for ORTHO-NOVUM Lots with Incorrect Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone/ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone/ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate® dispenser.

The potential risk of taking ORTHO-NOVUM without the appropriate instructions for correct use of the Veridate® dispenser pack is that the consumer could take the pills in the incorrect order (still receiving an effective dose) or could take an inactive "reminder" pill instead of an "active" pill which could lead to breakthrough bleeding or an unintended pregnancy.

ORTHO-NOVUM 1/35 and ORTHO-NOVUM 7/7/7 tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

For more information on this recall, read the company statement.

Kadesh Incorporated Issues Recall of Puriton Eye Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

Use of a non-sterile eye drop is potentially vision-threatening due to the risk of an eye infection. Additionally, the pH of the product is relatively high and can cause direct destruction of tissues in the cornea, anterior chamber and deeper structures of the eye which can lead to scarring, glaucoma or vision loss. To date, Kadesh, Inc. has not received any reports of adverse events related to this recall.

This product is an over-the-counter homeopathic eye drop for the temporary relief of burning and irritation due to dryness of the eye and discomfort due to minor irritations of the eye or to exposure to wind or sun. It is packaged in a 15 ml plastic bottle, NDC 7079600115, UPC 7 36972 1679 0. Kadesh, Inc. is voluntarily recalling all lots of Puriton Eye Relief Drops within expiry. The product was distributed nationwide via the company’s own online stores and retail distributors.

To learn more about this recall, consult the recall statement.

Barcelona Nut Company Issues Recall for Pistachio Products Potentially Contaminated with Salmonella

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that 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 roasted and salted in shell pistachios were distributed in Washington D.C., Maryland, Pennsylvania, Delaware, New York, California, Virginia, Ohio, New Jersey, and Georgia through retail stores and direct delivery. The pistachios are Barcelona Nut Company brand, packaged in Red White and Blue window plastic film

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

Sprout Creek Farm Recalls “Margie” Cheese Due to Listeria Monocytogenes Contamination

Sprout Creek Farm of Poughkeepsie, New York is recalling 132 wheels of "Margie" cheese, 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

Margie cheese is a soft, white rind, cow's milk cheese. It is packaged with a green round label, wrapped in white milk paper in one pound wheels. The cheese being recalled can be identified with the lot number make date of 10-9-18 and best by dates of 12-9-18.

The recall was the result of a routine US Food and Drug Administration inspection of Sprout Creek Farm's cheese production facility. During the inspection samples were sent to a FDA Lab for testing and Listeria monocytogenes was found in the product.

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

Duncan Hines Cake Mixes Recalled Due to Potential Contamination with Salmonella

Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same time period out of an abundance of caution.

Five occurrences of illnesses due to Salmonella are being researched by CDC and FDA as part of this investigation. Salmonella 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 persons infected with Salmonellaoften 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.

Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked. Consumers are reminded not to consume any raw batter. Cake mixes and batter can be made with ingredients such as eggs or flour which can carry risks of bacteria that are rendered harmless by baking, frying or boiling. Consumers are reminded to wash their hands, work surfaces, and utensils thoroughly after contact with raw batter products, to follow baking instructions, and to never eat raw batter.

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

Ganaderos Borges, Inc. Recalls Pork Products due to Possible Foreign Matter

Ganaderos Borges, Inc., a Naguabo, P.R. establishment, is recalling approximately 14,760 pounds of pork patty products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw pork patty items were produced on October 26, 2018.

The products subject to recall bear establishment number “EST. M32170” inside the USDA mark of inspection. These items were shipped to institutional locations in Puerto Rico.

The problem was discovered, and FSIS was notified, on Nov. 2, 2018 when the firm received a consumer complaint from a school that received the product. While the product was distributed to schools, it resulted from a commercial sale and was not part of food provided by the USDA for the National School Lunch Program.

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