Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point
Baltimore, Maryland, July 28, 2023: Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.
Food & Beverage Recalls
Ozona Organics Issues Voluntary Recall of Select Liquid Probiotic Products Due to Possible Health Risk
Ozona Organics, LLC of Ozona, Texas, is recalling its 4-ounce and 16-ounce bottles of Ozona Probiotics for Digestive Health (intended for human use), also labeled as GoHealthy Probiotics for Infants, Toddlers and Kids in 2-ounce bottles and GoHealthy Probiotics for Infants, Kids, Men and Women in 4-ounce bottles because they have the potential to become contaminated with microbial growth.
Ozona Organics is voluntarily recalling these products because of high water activity in the formula that provides a potential for microbial growth, which may be harmful. Although, no illnesses have been reported to date in connection with this problem.
Frito-Lay Issues Allergy Alert on Undeclared Soy and Wheat in Doritos Nacho Cheese Flavored Tortilla Chips Distributed in Pennsylvania
PLANO, Texas – August 1, 2023 – Frito-Lay has issued a voluntary recall of a limited number – less than 7,000 bags – of 14.5 oz and 1 oz Doritos Nacho Cheese Flavored Tortilla Chips that may contain undeclared soy and wheat ingredients from spicy sweet chili tortilla chips. Those with an allergy or severe sensitivity to soy or wheat run the risk of illness should they consume these products.
The products covered by this recall were distributed at retail stores only in Pennsylvania and other outlets, such as foodservice locations and vending machines. Consumers would have been able to purchase the chips as early as June 29, 2023.
No other Frito-Lay or Doritos products, flavors, sizes, or variety packs are recalled.
Medical Device Recalls
Baxter Issues Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ Infusion Pumps with Specific Software Versions
DEERFIELD, Ill., July 28, 2023 – Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps in the U.S. and Puerto Rico that have been upgraded to software versions v8.01.01 and v9.02.01. The Correction is due to an increase in reported false upstream occlusion alarms following the software upgrades. Baxter will be working with customers to revert the software on all affected pumps to the previous software version.
The upgraded software installed on Spectrum V8 and Spectrum IQ infusion pumps may cause an alarm for an upstream occlusion when there is no actual upstream occlusion present. This false alarm may lead to an interruption or delay of therapy. An interruption or delay of therapy may cause serious adverse health consequences in patients who are receiving life-sustaining medications. Baxter has received three reports of serious injury potentially associated with this issue.
Baxter representatives are contacting all affected customers to schedule the software reversion. Until the reversion is completed, false upstream occlusion alarms can occur on impacted pumps at a higher rate. Customers can continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions or referencing the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the Operator’s Manual. If a customer is unable to resolve an upstream occlusion alarm, they should unload and reload the set.
This Urgent Medical Device Correction applies to SIGMA Spectrum Infusion System (V8 Platform) with product code 35700BAX2 and software version v8.01.01 and Spectrum IQ Infusion System with Dose IQ Safety Software with product code 3570009 and software version v9.02.01.