Drug Recalls
Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
FOR IMMEDIATE RELEASE – 6/07/2022 – Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension, and two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension to the consumer level. The products are being recalled due to microbial contamination.
Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination
FOR IMMEDIATE RELEASE – June 07, 2022 – Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.
Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients
Walmart Inc. is voluntarily recalling all lots of Artri Ajo King Joint Supplements sold by Innovacion Naturals and PDX Supply Warehouse LLC on Walmart.com and shipped by Walmart to the consumer level. FDA laboratory analysis confirmed that Artri Ajo King Omega 3 Joint Support Supplement with LOTE LTARTKNGOMG30720, CADUCIDAD DICIEMBRE 2026, UPC 7 501031 111190 contains diclofenac not listed on the product label
Food & Beverage Recalls
F&S Fresh Foods Recalls 7.25oz Garden Highway Snacks Brand Protein Power Snack (UPC 8 26766 00979 4) Because of Possible Health Risk
F&S Produce Co of Vineland, NJ is recalling a limited quantity of Protein Power Snack, because it contains a cup of 0.75oz JIF peanut butter which has the potential of being 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.
Protein Power Snack was distributed at US Walgreens stores in NJ and NY.
The product has since been pulled from the shelves and is currently past the expiration date. The last lot of the affected product had a code date of “Best By: 05/28/22” which can be located on the front label.
Wilton Brands Issues Allergy Alert on Possible Presence of Undeclared Milk in Two Sprinkle Products
NAPERVILLE, Ill., June 2, 2022 (GLOBE NEWSWIRE) -- Wilton Industries, Inc. of Naperville, Illinois is initiating a voluntary national recall of select lots of Rainbow Chip Crunch Sprinkles And Rainbow Sprinkles Mix.
Although the product label does indicate that it may contain milk, this recall is being conducted because some samples of the product were found to contain milk.
People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The health and safety of our consumers is Wilton’s primary concern and Wilton is acting with the highest degree of caution and urgency to address this issue.
Taharka Brothers Ice Cream Recalls Peanut Butter Cup Ice Cream Because of Possible Health Risk
Taharka Brothers Ice Cream of Baltimore, Maryland is recalling its Peanut Butter Cup ice cream, because it has 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.
Affected Peanut Butter Cup ice cream was distributed between 03/01/2022 and 05/28/2022 to the Maryland and DC area through grocery stores, scoop shops, restaurants, and direct to consumer delivery.
The product comes in two forms, a 16 ounce paper pint container, which includes a design of peanut butter cups on a white background. The barcode on the side of the container will read 38455-78827. The product was also sold in brown, rectangular, cardboard containers measuring 2.5 gallons with a white sticker label reading Peanut Butter Cup.
Urban Remedy Recalls Urban Remedy Organic Revitalizing Tea Tonic - Strawberry Hibiscus Rose Due to Possible Hepatitis A Contamination
Urban Remedy is voluntarily recalling Urban Remedy Organic Revitalizing Tea Tonic Strawberry Hibiscus Rose (LOT 1232 BEST BY 7/17/2022) because it has the potential to be contaminated with Hepatitis A. Urban Remedy contracts Youngstown Grape Distributors Inc. to co-manufacture this product. The product may contain fresh organic strawberries linked to the FDA outbreak investigation of FreshKampo organic strawberries. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-hepatitis-virus-strawberries-may-2022.
Hepatitis A is a contagious virus that can cause liver disease. A Hepatitis A virus (HAV) infection can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. In rare cases, particularly consumers who have a pre-existing severe illness or are immune compromised, Hepatitis A infections can progress to liver failure. Illness usually occurs within 15 to 50 days after eating or drinking contaminated food or water. Symptoms of Hepatitis A infection include fever, headache, fatigue, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, jaundice, dark urine or pale stool. In some instances, particularly in children under the age of six, Hepatitis A infection may be asymptomatic.
Irvington Seafood Recalls “Crabmeat: Jumbo, Lump, Finger, and Claw Meat” Because of Possible Health Risk
Irvington Seafood of Irvington, AL, is recalling its 1 lb. packages of "Crabmeat: Jumbo, Lump, Finger, and Claw meat" because they have the potential to be contaminated with 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, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The recalled "Crabmeat: Jumbo, Lump, Finger, and Claw meat" were distributed to distributors located in Alabama, Georgia, Louisiana, and Mississippi.
The product comes in a 1 lb. containers, package marked with license number AL 111-C with the company name “Irvington Seafood.”
Please look for the following batch number written on the bottom of the container: 130, 131, 132, 134, 137, 139, 141, 144, 145, 146,148, 150
Leonard Novelty Bakery Announced a Recall Involving Carrot Cake Squares Due to Undeclared Walnuts
Leonard Novelty Bakery announced today a recall involving Carrot Cake Squares sold in our Bakery departments due to undeclared walnuts. These products (pictured below) bear the following UPC code 0-96162-12483-8. Affected lots include: SL21R 10222 12483, SL21R 10322 12483 and SL21R 10822 12483 and were sold from early May until May 17. This recall does not apply to any other lot codes of Carrot Cake Squares or other UPC codes or varieties of Cake Squares sold in our Bakery departments.
People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses or adverse reactions have been reported to date.
Guests who have purchased the product may return it to the store for a full refund. Guests with questions may contact Leonard Novelty Bakery at 201-296-0888 Monday through Friday, 9 AM to 4 PM EST.
Paris Brothers Inc. Voluntary Limited Recall
Paris Brothers, Inc., of Kansas City, Missouri is recalling several specific cheese products listed below because they have the potential to be contaminated with 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, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The following cheeses produced on May 4, 5, and 6, 2022 are the only products in the recall. Shipping cartons with the affected product will bear the lot codes of 05042022, 05052022, or 05062022. Individual retail outlets may have relabeled the individual consumer packages.
Medical Device Recalls
Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment
Deerfield, Ill. – 2022-06-01 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion (barotrauma) in the home care environment. These potential events may occur while using the Volara device in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit oscillation and lung expansion (OLE) therapy. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021.
As described in the Urgent Medical Device Correction, current patients should continue to use their Volara therapy as prescribed by their physician. Caregivers and/or patients should monitor for signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails, changes in alertness or drop in oxygen level) during Volara therapy when used in line with a ventilator. Caregivers and/or patients who observe signs of respiratory distress should stop the Volara therapy immediately. If patients do not see improvement after stopping the Volara therapy, they should seek medical attention. Baxter received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment.
In addition, Baxter will mitigate this risk by updating the Instructions For Use (IFU) manual to help ensure correct usage of the device. Once the updated IFU is available, Baxter will contact patients to arrange for a trainer to conduct a home visit to provide additional training. Baxter will also issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue.
This Urgent Medical Device Correction applies to Volara System model numbers PVL1HCBA; M08594; and M08594A with in-line VENTILATOR adaptor (M07937 MODULE, OPTIMUS HANDSET 2) or Volara Patient Circuit Kit (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT that include M07937).
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