November 2023 – 10/29– 11/4 – 8 Recalls (4 FDA, 4 USDA)

November 12, 2023 Robert Manning allergens, bacterial contamination, failure prevention, FDA, food, foodmanufacturing, foreign materials, FSIS, listeria monocytogenes, manning resource, prevent recalls, recall management, recall prevention, recall prevention checklists, robert w manning, undeclared ingredients, USDA 0 Comments

Current FDA & USDA Recall Trends

FDA

Recall / Contributing Factor(s)

11/1/23 -Drugs – OTC Ophthalmic Sterile Drops – Insanitary manufacturing conditions
- “Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility..” ¹
11/1/23 -Drugs – OTC Ophthalmic Sterile Drops – Insanitary manufacturing conditions
- “The Harvard Drug Group, LLC received information from FDA indicating investigator found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.” ²
10/31/23 – Food & Beverages – Wana Bana Apple Cinnamon Fruit Puree 2.5 oz – Elevated levels of lead.
- “Four illnesses have been reported to date, leading North Carolina Department of Agriculture and Consumer Services and the North Carolina Department of Health and Human Services to investigate and sample the pouches. North Carolina’s analyses came back with elevated concentrations of lead which could result in acute toxicity. WanaBana USA is working to investigate the source of the contamination..”³
10/30/23 -Animal & Veterinary, Food & Beverages – Dog Food, Select Beef Meal & Brown Rice Formula – Potential Salmonella contamination.
- “This voluntary recall was initiated after a third-party conducted random sampling and product associated with three lots tested positive for Salmonella.” ⁴

USDA

11/4/23 – Food – Chicken Patty Product – Possible foreign material contamination.
- “The problem was discovered after the firm notified FSIS that it had received consumer complaints reporting small metal pieces in the chicken patty product. There has been one reported minor oral injury associated with consumption of this product. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.” ⁵
11/2/23 – Food – Frozen Spaghetti Loops with Meat Sauce Entrée Products – Misbranding and undeclared allergens.
- “The problem was discovered by the producing establishment while conducting a routine ingredient label review. They notified FSIS that egg, a known allergen, was not declared on the finished product label. The problem occurred after a change in noodle formulation by the supplier.” ⁶
10/31/23 – Food – RTE Empanada Products – Products produced without the benefits of inspection.
- “The problem was discovered during FSIS surveillance activities when it was determined that the empanada products did not have the USDA mark of inspection and were produced in a facility that was not inspected by USDA. The products were also distributed without a list of ingredients. As a result of not receiving inspection, FSIS is concerned these products may not be safe for human consumption.” ⁷
10/30/23 – Food – RTE Ham Products – Imported without the benefits of reinspection.
- “The problem was discovered during routine FSIS surveillance activities of imported products, and it was determined that the products were not presented for reinspection.” ⁸