FDA recall D-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.

Reason for recall

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

Distribution

Kansas and California.

Key facts

Status

Terminated

Initiation date

2012-05-08

Report date

2012-08-08

Termination date

2012-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1433-2012