FDA Drug Alerts and Statements
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Wells Pharma of Houston, LLC – 713015 – 11/07/2025
Compounding Pharmacy/Adulterated Drug ProductsContinuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy
BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death.Mark J. Savant, M.D – 712306 – 06/26/2025
Clinical InvestigatorAcme United Corporation – 712324 – 10/10/2025
CGMP/Finished Pharmaceuticals/AdulteratedAbbreviated New Drug Application (ANDA)
Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicantsMiddlefield 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 Jack