BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death.
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Park Avenue Compounding. Saint Louis, MO. 483 issued 09/23/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/23/2025
Short Title (70 char) Park Avenue Compounding. Saint Louis, MO. 483 issued 09/23/2025
FEI Number 1972829
Firm Name Park Avenue Compounding
Record Type 483
State MO
Establishment Type Outsourcing FacilSecret Miracle Honey Extra Strength may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Secret Miracle Honey Extra Strength, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.Tower Laboratories Ltd. – 717456 – 12/23/2025
CGMP/Finished Pharmaceuticals/AdulteratedOlympus Announces Voluntary Corrective Action for the Single-Use Ligating Device
Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device (“Polyloop”) following identification of a potential safety issue.Counterfeit Medicine
Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients.FDA use of Real-World Evidence in Regulatory Decision Making
The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.