Overall, the results remained robust in several sensitivity analyses
The product was removed from refrigerated storage for an extended period of time.Recall Initiation Date: April 9, 2025Link: FDA Enforcement Report Facility Inspections FDA Warning Letters ProRx, LLC Type: Compounding pharmacy and FDA-registered outsourcing facilityFDA Department issuing Warning: Center for Drug Evaluation and Research (CDER)Warning Letter Date: January 15, 2025Facility Location: Exton, PennsylvaniaInspection Dates: July 15, 2024, to August 2, 2024
The US-headquartered firm emphasised that Mounjaro is a prescription-based medicine and approved as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with obesity
The clinical efficacy is real, the safety profile is well-characterised, and the supply chain is now properly cold-chain-audited
If patients develop NAION after using Ozempic, they should seek immediate medical care
