A newsletter on regulatory science for CDER’s stakeholders
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Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits
Medline is removing certain anesthesia circuit kits due to cracks and leaks in the tubing.BRS Analytical Services, LLC – 711133 – 09/17/2025
CGMP/Finished Pharmaceuticals/AdulteratedMiddlefield Original Cheese Co-Op Recalls 100% Grass-Fed Pepper Jack Cheese and Horseradish Flavored Cheese Due to Possible Listeria monocytogenes Contamination
Middlefield, OH 8/15/25 – The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling 246.5 Lbs. of 100% Grass-fed Pepper Jack Cheese, sold in 8 oz. packages, 5 lb. loaves and 40 lb. loaves, 2.5 Lbs. of Horseradish Flavored Cheese, sold in 8 oz. packages, 640 Lbs. of Monterey JackFirst Generic Drug Approvals
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patiEarly Alert: TactiFlex Ablation Catheter Issue from Abbott
Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issuesLOVION Chocolate with Ginseng for Men may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use LOVION Chocolate with Ginseng for Men, a product promoted and sold for sexual enhancement on various websites, including lovionusa.com, and possibly in some retail stores.