FDA Recalls February 12 24, 2022

Animal & Veterinary Recalls

Family Dollar Stores Issues Voluntary Recall of Certain FDA-Regulated Products in Six States Including Drugs, Devices, Cosmetics, Foods

Family Dollar, Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the present due to the presence of rodents and rodent activity at Family Dollar Distribution Center 202.

Drug Recalls

TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene

FOR IMMEDIATE RELEASE – February 16, 2022 – Westport, Connecticut, TCP HOT Acquisition LLC dba HRB Brands is voluntarily recalling all lot numbers with expiration dates on or before August 2023 of the Sure and Brut Aerosol Sprays listed in the table to the consumer level due to the presence of benzene. While benzene is not an ingredient in any of the recalled products, our review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. These products were owned and distributed by Helen of Troy Limited prior to June 7, 2021.

Food & Beverage Recalls

Dried Plums Recall Information

IDENTIFYING FEATURES
Barcode: 810019600821
Item code: 1516905 Dates available for sale: April 2021 - February 2022.
Sold at Costco Wholesale in four states: Alaska, California, Oregon and Washington.

WHAT ARE THE DEFECTS?
Alli & Rose LLC has announced a recall due to the potential presence of lead.

Vadilal Industries (USA) Recalls "Custard Apple Pulp" Because of Possible Health Risk

Vadilal Industries (USA) Inc. of Newark, NJ is voluntarily recalling two batches of frozen Custard Apple Pulp 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.

The product was distributed nationwide through retail stores and is sold in 35.27-ounce packets. The packets are labeled as “Custard Apple Pulp” and the batch codes are printed on the back of the packet. 

Abbott Voluntarily Recalls Powder Formulas Manufactured at One Plant

Abbott (NYSE: ABT) is initiating a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Mich., one of the company's manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas.

Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.

Lehi Valley Trading Company Issues Allergy Alert on Undeclared Peanut Allergen in Yogurt Raisins

In cooperation with the FDA Lehi Valley Trading Company of Mesa, Arizona is issuing a nationwide recall of 8,10 and 12.3 oz packages of Yogurt Raisins, because it may contain undeclared Peanut Allergen. People who have an allergy or severe sensitivity to Peanut Allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

Yogurt Raisins in question are

1. Snack-Worthy 10 oz Yogurt Raisins, UPC 7911400668 with Best By date 09/12/22 and Lot Code 222268 packaged in a clear tub with front and back labels.
2. Woody’s Smokehouse 12.3 oz Yogurt Raisins, UPC 9524865531 with Best By date Aug 23, 2022 packaged in a clear plastic bag with front and back labels.
3. Texas Best Smokehouse 8 oz Yogurt Raisins, UPC 9524832055 with Best By date Aug 23, 2022 packaged in a clear plastic bag with front label

Candies Tolteca Recalls “Saladitos” Salted Dried Plums and “Saladitos Con Chile Y Limon” Dried Plums with Chili & Lemon Because of Possible Health Risk

Candies Tolteca of Fresno, California is recalling all 1.5 oz packages of Saladitos (Salted Dried Plums) and all 1.5 oz packages of Saladitos con Chile y Limon (Dried Plums with Chili & Lemon) because it has the potential to be contaminated with lead.

The Royal Ice Cream Company, Inc. Expands Recall All Products Within Expiry Because of Possible Health Risk

The Royal Ice Cream Company, Inc. of Manchester, CT is expanding its recall to include all products manufactured at the facility within expiry, 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.

All effected products will have the manufacturing plant number “CT121” or “CT#121”.

Medical Device Recalls

Baxter Issues Urgent Safety Communication to Reinforce Important Safety Information Regarding Upstream Occlusion Alarms for all Spectrum V8 and Spectrum IQ Infusion Pumps

Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication, in some cases without alerting the user via pump alarm. Baxter previously communicatedExternal Link Disclaimer this information to customers via an Urgent Safety Communication notification on December 29, 2021.

Customers notified Baxter that the pump was not delivering medication at the programmed rate displayed on the screen, and in some cases was not alarming for upstream occlusions. As described in the Urgent Safety Communication notification, after an upstream occlusion alarm, it is imperative to fully resolve any upstream occlusion before restarting the pump. Failure to do so may cause the pump not to re-alarm as expected, which can lead to interruption in therapy and/or under-infusion. The potential harm to the patient depends on several factors such as length of therapy delay, medication being infused, volume and rate of infusion, and the patient’s underlying status and comorbidities. To date, Baxter has received 51 reports of serious injury and three reports of patient death over five years that may have resulted from incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms.