Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot 87100040
Why it was recalled
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Recalling firm
- Firm
- Bayer HealthCare Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Columbia Rd, N/A, Morristown, New Jersey 07960-4526
Distribution
- Quantity
- 194.62 kg
- Distribution pattern
- NY, CA
Timeline
- Recall initiated
- 2013-06-13
- FDA classified
- 2013-07-18
- Posted by FDA
- 2013-07-24
- Terminated
- 2014-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-807-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.