Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
Food & Beverage Recalls
Green Field Farms Dairy of Fredericksburg, Ohio announces a voluntary recall of its Whole Chocolate Milk product, with a code date of 9/29/21, due to a laboratory analysis that indicated this product was not effectively pasteurized.
1,242 units of the affected product were distributed in Ohio, Indiana, Kentucky, Maryland, New Jersey, New York, Pennsylvania, Virginia, Delaware and Washington DC from September 7 through September 16, 2021. This quality issue is isolated to Whole Chocolate Milk with an expiration date of September 29, 2021.
Joy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand.Coriander chutney because it contains undeclared sulfites.coconut. FD&C YELLOW#5 . People who have allergies to sulfites.coconut and FD&C YELLOW#5 run the risk of serious or life-threatening allergic reaction if they consume this product.
The recalled Joy Brand Chutney was distributed in NY, NJ,PA in retail stores.The product comes in 8 oz, clear glass jar packages and marked on the labels as follows:
CORIANDER CHUTNEY 8 OZ
BEST BY:07302022 BARCODE: 680617 60402
The product code can be found on the front of the bottle
Baker Farms is recalling their Baker Farms, Kroger & SEG Grocers brand names of Kale, 1 lb plastic bags with BEST BY 09-18-2021 107020-21832 due to 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 9-15-2021 the firm was notified by a customer that the product test positive for Listeria monocytogenes. The products were distributed between 8/30/2021 – 9/1/2021. These products were packaged in clear plastic bags and sold to distribution centers located in the States of: AL, AR, FL, GA, KS, MO, MS, NC, NY, OH & VA. The previous press release incorrectly listed the State of Louisiana and failed to list the States of Kansas and Ohio
The Kroger Co. Issues Voluntarily Recall on 16-Ounce Kroger Bagged Kale Due to Possible Listeria Monocytogenes Contamination
The Kroger Co. (NYSE: KR) is voluntarily recalling its 16-ounce Kroger bagged kale product, produced by Baker Farms, due to possible listeria monocytogenes contamination.
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. To date, we have not received any reports of illness related to the consumption of this bagged kale product.
This voluntary recall includes 16-ounce bags of Kroger branded Kale (see picture below), with the UPC 11110-18170 with a best by date of 09-18-2021, which is printed on the front of the package below the light blue bar.
All affected products were pulled from our Produce departments on Sept. 16, 2021.
Drew’s Organics, LLC Issues Voluntary Recall of Aldi Simply Nature Organic Poppy Seed Dressing for Potential Clostridium botulinum Contamination
Drew’s Organics, LLC of Chester, VT is voluntarily recalling one lot code of Aldi Simply Nature Organic Poppy Seed Dressing due to a processing issue that could allow for microbial growth.
The recalled product comes in a 12 fl. oz. glass bottle with the Best if Used By date of Feb 15 2023, and UPC #4099100023169. The lot code is printed on the shoulder of the bottle above the label.
This action is being taken in cooperation with the US FDA. Product has been distributed to select Aldi stores between August 20th and September 10th in the following states Alabama, Arizona, California, Connecticut, Delaware, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin, and West Virginia.
Buurma Farms Inc. of Willard, OH, is voluntarily recalling 320 boxes of its Plain Parsley after testing showed possible contamination with Shiga-toxin producing E.coli.
The product being recalled is Buurma Plain (flat leaf) Parsley with a harvest date of August 30, 2021 from their Gregory, Michigan location. A random, routine regulatory sample collected on 9/7/21 at a customer’s distribution center by the Michigan Department of Agriculture and Rural Development (MDARD) tested positive for non-O157 STEC (Shiga-toxin producing E. Coli) and reported 9/13/21. The sample is currently being genome sequenced to determine if it is pathogenic but out of an abundance of caution the product is being recalled. Buurma Farms Inc. is coordinating closely with regulatory officials in connection with the recall. No illnesses have been reported to date.
Seviroli Foods Voluntarily Issues a Recall of H-E-B Jumbo Stuffed Shells - 22 Oz Due to Potential Presence of Foreign Material
Committed to the quality of its products and out of an abundance of caution, SEVIROLI FOODS, INC, of Bellmawr, NJ is recalling H-E-B Jumbo Stuffed Shells - 22 oz due to potential presence of foreign material in product (Metal). Consumption of hard or sharp foreign material could cause physical injury. The affected products were distributed to H-E-B stores in Texas.
The issue was discovered on September 09, 2021, after H-E-B was notified of four customer complaints. All product related to this recall has been removed from H-E-B store shelves.