Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter
Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.
Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.
Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.
Food & Beverages Recalls
Out of an abundance of caution, EVR Foods, INC, parent company to Lavva, is issuing a voluntary recall on its 5.3 ounce Blueberry Plant-Based Yogurt with expiration date 2/21/21. While this SKU and date code cleared strict quality assurance protocols, recent testing indicates a potential mold contamination. No other Lavva products are affected by the recall.
This plant-based yogurt was produced at a manufacturing facility in Norwich, NY, and has only been linked to the single date code. There have been no confirmed illnesses to date.
The recalled Blueberry Plant-Based Yogurts were distributed to retail stores nationwide. The product comes in a 5.3 ounce, colorful plastic cup with a foil lid, marked with lot #022121 on the bottom of the cup which is also used as the expiration date of the product.
Weis Markets today said it has issued a recall for:
- 10,869 containers of Weis Quality Cookies and Cream Ice Cream (48 oz.), and
- 502 bulk containers of Klein’s Vanilla Dairy Ice Cream (3 gallon)
because the products may be contaminated with extraneous material, specifically metal filling equipment parts. There has been one report of a customer who discovered an intact piece of metal equipment in the Weis Quality Cookies and Cream Ice Cream (48 oz). There is concern of an additional piece of equipment present in the ice cream product(s) possibly presenting a choking hazard.
The Weis Quality Cookies and Cream Ice Cream (in 48 oz. containers) product has been removed from sale. It was sold in 197 Weis Markets’ stores in Pennsylvania, Maryland, Virginia, New Jersey, New York, Delaware and West Virginia.
Dole Fresh Vegetables Announces Limited Voluntary Recall of Dole™ Sesame Asian Chopped Salad Kit Due to Undeclared Allergens
Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of Dole™ Sesame Asian Chopped Salad Kit.
This voluntary recall is due to possible undeclared allergens (egg) in Dole™ Sesame Asian Chopped Salad Kit. The dressing and topping kit (masterpack) designed for a different Dole product was unintentionally used during a portion of the production of the salad. Dole Fresh Vegetables, Inc. is coordinating closely with regulatory officials. No illnesses or allergic reactions have been reported to date in association with the recall. However, people who have an allergy to eggs may have a serious or life-threatening allergic reaction if they consume this product or products containing eggs.
The product lot code and Best if Used by Date is located on the upper right corner of each bag and the UPC code is located on the bottom right corner of the back of each bag. The impacted products were distributed in AK, CA, ID, KS, MO, OK, OR, TX AND UT.
Medical Devices Recalls
Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation
Boston Scientific Corporation (NYSE: BSX) has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant. There is no safety issue for patients who currently have an implanted LOTUS Edge valve.
Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire LOTUS product platform immediately. All related commercial, clinical, research & development and manufacturing activities will also cease.