Recent Recalls You Should Know About—Week of June 10, 2018

We’ve rounded up a list of important US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) from this past week:

Caito Foods Issues Voluntary Recall of Pre-Cut Melon Linked to Multistate Salmonella Outbreak

Caito Foods is voluntarily recalling fresh-cut watermelon, honeydew melon, cantaloupe, and fresh-cut mixed fruit containing 1 of these melons, produced at the Caito Foods facility in Indianapolis, Indiana because these products may be contaminated with Salmonella. The use or consumption of products contaminated with Salmonella may result in serious illness.

Reports of illnesses linked to these products are under investigation, and Caito Foods is voluntarily recalling the products out of an abundance of caution. The company has been advised by the US Centers for Disease Control and Prevention (CDC) that it has linked 58 illnesses to the strain of Salmonella under investigation. The products were packaged in clear, plastic, clamshell containers and distributed in Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina and Ohio.

For the complete list of recalled melon products, read the official statement.

HF Foods Recalls Pork Products Issued Without Benefit of Inspection

HF Food Distributors, an Orocovis, Puerto Rico establishment, is recalling approximately 142 pounds of sliced cooked ham products that were produced without the benefit of federal inspection, the US Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced this week.

The ready-to-eat sliced cooked ham products were produced and packed on April 21, 2018. The following products are subject to recall:

• 1-lb. plastic-wrapped packages of “JAMON COCIDO REBANADO” with a sell by date of “May 25, 00” on the label.

The products do not bear an establishment number, mark of inspection, or an ingredients statement. These items were shipped wholesale to Head Start centers in Puerto Rico. USDA provides reimbursement for meals served in Head Start through the Child and Adult Care Food Program; however, these products were purchased commercially. The products were not provided or purchased by USDA’s Food and Nutrition Service.

For more information, check out the official news release.

Venda Ravioli Expands Recall of Poultry Pasta Without Benefit of Inspection

Venda Ravioli, Inc, a Providence, Rhode Island establishment, is recalling approximately 738 pounds of frozen meat ravioli products that were produced without the benefit of federal inspection while the establishment was under suspension, according to the US Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The scope of this recall expansion now includes an additional 66 pounds of frozen meat and poultry pasta products, which were produced and packed from February 22, 2018, through June 7, 2018.

• 16 oz. sealed trays of “VENDA RAVIOLI, PASTA FRESCA, COSTANTINO’S, Chicken Prosciutto Ravioli,” and a lot code of 05318-15918.
• 16 oz. sealed trays of “VENDA RAVIOLI, PASTA FRESCA, COSTANTINO’S, Chicken Prosciutto Walnuts Ravioli,” and a lot code of 05318-15918.
• 16 oz. sealed trays of “VENDA RAVIOLI, PASTA FRESCA, COSTANTINO’S, Chicken Tortelloni,” and a lot code of 05318-15918.

The problem was discovered on June 12, 2018, while FSIS was performing recall effectiveness checks. The items were shipped to retail locations in Rhode Island.

For more information read the official statement.

Kellogg Recalls Honey Smacks Due to Potential Contamination with Salmonella

Kellogg Company announced it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg’s Honey Smacks cereal because these products may contain Salmonella. No other Kellogg products are impacted by this recall.

Kellogg launched an investigation with the third-party manufacturer who produces Honey Smacks immediately after being contacted by the FDA and CDC regarding reported illnesses.

For more information: https://www.fda.gov/Safety/Recalls/ucm610815.htm

FDA’s Investigation into Guardian’s Compounded Triamcinolone-Moxifloxacin Drug Product

On July 28, 2017, the FDA alerted health care professionals of adverse event reports concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone acetonide (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields.

In May 2017, the FDA collected 1 vial of Guardian’s triamcinolone-moxifloxacin product with a beyond use date of February 3, 2017, from the PRG Dallas Ambulatory Surgery Center in Dallas, Texas. In December 2017, the FDA collected 7 vials of Guardian’s product with a beyond use date of November 10, 2016, from the Texas State Department of Health. In March 2018, 2 additional vials of Guardian’s product were shipped from the Texas State Department of Health to FDA.

The FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants and prepared in-house samples of Guardian’s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian’s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.

For more information about the FDA’s investigation, check out the official statement.