FDA recall D-807-2013

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

Reason for recall

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Distribution

NY, CA

Key facts

Status

Terminated

Initiation date

2013-06-13

Report date

2013-07-24

Termination date

2014-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morristown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-807-2013