PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 8, 2012 Initiated: May 8, 2012 #D-1433-2012

Product Description

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.

Reason for Recall

Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.

Details

Units Affected
112.295 kg
Distribution
Kansas and California.
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bayer HealthCare Pharmaceuticals Inc.. Units affected: 112.295 kg.
Why was this product recalled?
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 8, 2012. Severity: Moderate. Recall number: D-1433-2012.