Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Reason CGMP Deviations
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Reason Presence of Foreign Substance; Broken metal piece found embedded in tablet.
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