Drug Recalls
Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination
FOR IMMEDIATE RELEASE – 04/29/2022 – St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli.
Burkholderia gladioli is an opportunistic pathogen most commonly affecting patients with respiratory disease. Patients with compromised immune systems such as those with Cystic Fibrosis are at higher risk. Burkholderia gladioli also can cause complications after transplants. Exposure to contaminated product could lead to adverse events, which could be severe for at-risk individuals. Fagron has received three complaints regarding an undesirable smell associated with the product. To date, Fagron has not received any reports of adverse events related to the product being recalled.
Food & Beverage Recalls
Natural Organics, Inc. Issues Nationwide Voluntary Recall on Four Lots of NaturesPlus Keto Living Sugar Control, 90 Capsules Due to Possible Health Risk
Natural Organics, Inc., is voluntarily recalling four lots of NaturesPlus Keto Living Sugar Control Capsules 90 count, because it was found to contain gluten. People who have allergies to wheat or gluten run the risk of serious or life-threatening allergic reactions if they consume these products. Individuals with Gluten intolerance may experience minor to severe reactions after consuming this product. This could include upset stomach, diarrhea, fatigue, skin reactions and more.
Dymski Pierogies DBA Grandma’s Cuisine Issues Allergy Alert on Undeclared Milk in Frozen Cheese Filled Pierogis
Dymski Pierogies dba Grandma’s Cuisine of East Stroudsburg, PA is recalling multiple varieties of frozen cheese-filled pierogis because it may contain undeclared milk allergen. 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.
Grandma’s Cuisine branded pierogis were distributed in Restaurant Depot chain stores and local retail stores in NY, NJ, and PA. Bernat’s branded pierogis were distributed to retail stores in MA. Golden Eagle brand pierogis were distributed to retail stores in NJ. Recalled product was distributed between April 2021 and April 2022.
The recalled products are sold in 1lb and 3lb plastic bags under the brands: Grandma’s Cuisine, Bernat’s, Golden Eagle.
New Seasons Market Issues Allergy Alert on Undeclared Peanuts in Matiz Valencia Almonds
New Seasons Market LLC is recalling Matiz Valencia Almonds because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
The Valencia almonds were distributed in Oregon and Washington to New Seasons Market stores for retail sale in the cheese department.
Queen Bee LLC Voluntary Recall
“When a Government Agency Partner announces a company’s recall, market withdrawal, or safety alert, the FDA posts the Government Agency Partner’s announcement as a public service. FDA does not endorse either the product or the company.”
On April 28, 2022, Queen Bee LLC (Lovell, WY) issued a voluntary recall of candy products purchased within the last year. The voluntary recall impacts a variety of honey caramel candy products and chocolates that may contain undeclared allergens including tree nuts and dairy (milk).
The impacted products were sold at Queen Bee Gardens and were also distributed via retail, wholesale, and direct sales nationwide with production dates through April 26, 2022. The undeclared tree nut allergen issue was identified as part of a result of a routine food safety inspection and the incorrectly labeled milk and tree nut allergen was the result of a label review. People who have an allergy or severe sensitivity to Tree Nuts (macadamia nuts, coconut, pecans, walnuts, almonds, and cashews) and dairy (milk) may risk serious or life-threatening allergic reaction if they consume these products.
The TJX Companies, Inc. Issues Allergy Alert on Undeclared Milk in Certain Vegan Chocolate Products
The TJX Companies, Inc. of Framingham, MA is recalling certain vegan chocolate products because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reactions if they consume these products. The products being recalled are:
- “Pimlico Confectioners Vegan Fine Hazelnut Truffles” in a 3.88-ounce green plastic package.
- “Keats London Vegan Hazelnut Dark Chocolate” in a 4.93-ounce round green plastic package.
- “Keats London Vegan Irish Cream Truffles” in a 4.93-ounce round blue plastic package.
All product codes for these items are included in the recall.
The products recalled were distributed at TJX retail stores nationwide. TJX operates T.J. Maxx, Marshalls, HomeGoods, Sierra, and Homesense.
Specific Items Containing H-E-B Bakery Two Bite Brownies Manufactured by an Outside Supplier Voluntarily Recalled for Potential Presence of Metal Fragments
H-E-B is voluntarily issuing a recall for H-E-B Bakery Two Bite Brownies (12 oz) and H-E-B Simply Delicious Cookies with Brownie Bites Party Trays for potential metal fragments in product. The potentially affected products were manufactured by an outside supplier and distributed only to H-E-B and Joe V’s Smart Shop stores in Texas and Mexico.
All products related to this recall have been removed from store shelves. H-E-B made the decision to issue a recall upon investigation of two consumer complaints. As soon as we confirm that the product meets our high quality and safety standards, H-E-B will have the products back on shelves.
Medical Device Recalls
Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family
Amsterdam, the Netherlands – Royal PhilipsExternal Link Disclaimer (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics has already notified the relevant competent authorities.
Philips Respironics has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance. Philips Respironics projects an average of less than one silent shutdown among one million uses per year.
Read Comments