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
Reported: July 24, 2013 Initiated: June 13, 2013 #D-807-2013
Product Description
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.
Details
- Recalling Firm
- Bayer HealthCare Pharmaceuticals Inc.
- Units Affected
- 194.62 kg
- Distribution
- NY, CA
- Location
- Morristown, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bayer HealthCare Pharmaceuticals Inc.. Units affected: 194.62 kg.
Why was this product recalled? ▼
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2013. Severity: Low. Recall number: D-807-2013.
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