Drug 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
D-807-2013
Product summary
- Event
- Event 65702
- Status
- Terminated
- Classification
- Class III
- Quantity
- 194.62 kg
- Official record key
drug-enforcement:D-807-2013
Official wording
Reason: Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Code information: Lot 87100040
Distribution pattern: NY, CA
Derived failure modes
-
Potency or specification failure
Out of specification