Bayer HealthCare Pharmaceuticals Inc. recalls Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (l
Recalled July 24, 2013 · FDA recall D-807-2013 · Bayer HealthCare Pharmaceuticals
Hazard
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. · FDA Class III
Units
194.62 kg
Sold at
NY, CA
Description
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Product
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
Manufacturer(s)
Bayer HealthCare Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →