FDA-Drug2013-07-24Class III
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
Bayer HealthCare Pharmaceuticals Inc.
Hazard
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Sold states
NY, CA
Affected count
194.62 kg
Manufactured in
36 Columbia Rd, N/A, Morristown, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-807-2013Don't want to check this manually?
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