August 4, 2024 – August 10, 2024 – 10 Recalls (10 FDA, 0 USDA)

August 13, 2024 Bob Manning allergens, author, bacterial contamination, canned meat, checklists, contamination, drugs, failure prevention, FDA, food, foodandbeverage, foodmanufacturing, foreign materials, FSIS, listeria monocytogenes, manning resource, prevent recalls, recall advisor, recall field guide, recall management, recall prevention, recall prevention checklists, recall prevention guide, robert w manning, salmonella, undeclared ingredients, under processed, USDA 0 Comments

Industries: Prepared Foods, Confections, Medical Devices, Infant Formula, Drugs, Fish

Current FDA & USDA Recalls

FDA

Recalls / Contributing Factor(s)

8/9/24 – Food & Beverage – Steam Buns with Egg Custard Added & Steam Buns with Egg Custard and Coconut Added – Undeclared Sesame.
- “The mislabeling was identified internally. No customer complaints or illnesses have been reported to date. The recall was initiated after it was discovered that 6 cases of Sesame Steamed Buns may have been packaged in Egg Custard Steam Bun packaging. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s packaging processes, which has been corrected..” 1
8/9/24 – Food & Beverage – Dunking Cookies Chocolate Chip – Undeclared Milk.
- “The product contains a milk allergen that was mistakenly not listed in the ingredient declaration and Contains statement. Meijer was not notified of the label inaccuracy.” 2
8/9/24 – Medical Devices – Vivo 45 LS (US Version) Ventilator – Potential for short term elevated levels of formaldehyde exposure.
- “On August 5, 2024, Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness such as asthma in small pediatric patients resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support).” 3
8/8/24 – Food & Beverage – Premium Infant Formula with Iron Milk-Based Powder – Product contains levels of Vitamin D above the maximum level permitted.
- “The Company is initiating this voluntary recall in consultation with the U.S. Food and Drug Administration (FDA). There have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the product subject to this recall, which was determined through routine testing.” 4
8/8/24 – Drugs – 9% Sodium Chloride for Injection USP 1000 mL in E3 containers – Potential for particulate matter and fluid leakage of the containers.
- “The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.” 5
8/6/24 – Food & Beverage – Cold Smoked Capelin – Potential to be contaminated with Clostridium botulinum.
- “The sale of uneviscerated fish over 5” in length may contain Clostridium botulinum spores as they are more likely to be concentrated in the viscera than any other portion of the fish. Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.” 6
8/7/24 – Food & Beverage – Yummy Swirly Ices, various flavors – Undeclared Milk Allergen.
- “The recall was initiated after an allergen sensitive consumer complained about feelings of discomfort after consuming the Swirly Ices. The reason for the cross contamination is still under investigation.” 7.
8/6/24 – Drugs – Heparin Sodium in 0.9% Sodium Chloride Injection – Elevated endotoxin levels.
- “Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.” 8
8/6/24 – Food & Beverage – Coconutmilk Chocolate Almond Crunch Frozen Dessert– Undeclared Cashew Allergen.
- “G.S. Gelato was notified by one of the retail stores that the product carton and lid stated two different products. The firm conducted an investigation which determined that a single lot of pints of cashewmilk product was dispensed into the Full Circle Market brand Coconutmilk pints during the manufacturing process.” 9
8/4/24 – Food & Beverage – Moong Dal, Crunchy Green Gram – Potential Contamination with Salmonella.
- “Thal Golden Spices Inc recently discovered an oversight in the distribution process of one of our products. Unfortunately, the product was released without proper lab results. This issue came to light during an FDA inspection when inspectors identified discrepancies in the batch numbers slated for destruction. We are actively addressing this situation to ensure compliance and rectify the error.” 10