Recalls That Should Be on Your Radar—Week of June 23, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Keurig Dr Pepper Issues Recall for Peñafiel Mineral Water Due to High Levels of Arsenic

Keurig Dr Pepper today announced it will voluntarily withdraw Peñafiel unflavored mineral spring water products, imported from Mexico, due to the presence of violative levels of arsenic. Arsenic when present in the diet at very high levels, well above those detected in recent samples of Peñafiel, is associated with numerous chronic diseases. Water quality tests of Peñafiel samples conducted by an independent laboratory on behalf of Keurig Dr Pepper detected arsenic at levels that exceeded the FD!’s bottled water standards for mineral water of 10 ppb.

All unflavored Peñafiel mineral spring water products including 600mL and 1.5L of all date codes are included in this voluntary withdrawal. The product is packaged in PET bottle formats.

Arsenic is found in nature, including in aquifers that are the source of mineral water and where levels can vary over time. Keurig Dr Pepper has recently installed enhanced filtration systems at its facilities that produce Peñafiel, and the product now being produced is well within regulatory guidelines.

Read more about this recall here.

Brand Castle, LLC Issues Recall for Glass Jar Baking Mixes Due to Health Risk

In cooperation with ADM Milling Co., Brand Castle, LLC of Bedford Heights, Ohio is voluntarily recalling 25 oz and 32 oz glass jars of cookie and brownie mix out of an abundance of caution because it may be contaminated with pathogenic E. coli.

The product is being recalled because an ingredient supplier, ADM Milling Co., has issued a recall for the flour used in these products due to E. coli contamination found in a single lot code of H&R Flour at their Buffalo production plant.

E. coli symptoms include severe stomach cramps, diarrhea (often bloody) and vomiting. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.

Read more about this recall here.

Perrigo Issues Recall for Parent’s Choice Infant Formula Due to Possible Foreign Matter Contamination

Perrigo Company plc is issuing a voluntary nationwide recall of 35-ounce, 992-gram containers of Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron. This product, sold exclusively at Walmart, is being recalled because of the potential presence of metal foreign matter in a single lot of the product (C26EVFV). The total number of containers affected by this recall is 23,388.

No adverse events have been reported to date, and the recall is being initiated out of an abundance of caution stemming from a consumer report. No other products or retailers are affected by this recall.

Consumers who may have purchased the product should look for Lot Code C26EVFV with a "use by" date of February 26, 2021, which can be found on the bottom of the package. Any consumers who purchased the product should discontinue use and can visit any Walmart store for a refund.

Read more about this recall here.

Teleflex Inc. Issues Recall of Select Hudson RCI Sheridan Endotracheal Tubes

Teleflex Incorporated (NYSE: TFX), has announced a worldwide recall of certain lots of Hudson RCI@ Sheridan@ Endotracheal Tubes. The recalled products are designed for oral or nasal intubation and are indicated for airway management.

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). The immediate consequence for patients is disconnection from the breathing circuit, which may result in insufficient oxygenation, requiring medical intervention. There have been four reports of death, and additional reports of serious injury where ETT disconnection may have been a factor.

The U.S. Food and Drug Administration (FDA) has classified the recall of Hudson RCI® Sheridan® Endotracheal Tubes as a Class I recall. FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Read more about this recall here.

San Giuseppe Salami Co by Giacomo Issues Recall for Sausage Products due to Possible Foreign Matter Contamination

San Giuseppe Salami Co. by Giacomo, an Elon, N.C., establishment, is recalling approximately 832 pounds of ready-to-eat (RTE), frozen andouille sausage products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall bear establishment number “EST. 21556” inside the USDA mark of inspection. These items were shipped to retail and institutional locations in Greensboro, N.C.

The firm contacted FSIS after they received a report that a consumer found a piece of a metal ring in the product.

Read more about this recall here.