Recalls / Class II
Class IID-1433-2012
Product
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
- Affected lot / code info
- Lot Number: 81202450, Exp 06/15/16
Why it was recalled
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Recalling firm
- Firm
- Bayer HealthCare Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6 W Belt Plz, N/A, Wayne, New Jersey 07470
Distribution
- Quantity
- 112.295 kg
- Distribution pattern
- Kansas and California.
Timeline
- Recall initiated
- 2012-05-08
- FDA classified
- 2012-07-31
- Posted by FDA
- 2012-08-08
- Terminated
- 2012-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1433-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.