FDAFDA · Food and drugs·Recall number D-807-2013
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
Published July 24, 2013 · Recall initiated: June 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc.
- Distributor
- NY, CA
- Lot
- Lot 87100040
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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