Status
Terminated
Drug Enforcement D-1433-2012
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Classification
Class II
Report Date
August 8, 2012
Termination Date
December 18, 2012
Product Information
- 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.
- Product quantity
- 112.295 kg
- Reason for recall
- Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Kansas and California.
Location & Firm
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Address
-
6 W Belt Plz, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1433-2012
- Event ID
- 62651
- Recall initiation date
- May 8, 2012
- Center classification date
- July 31, 2012
- Code info
- Lot Number: 81202450, Exp 06/15/16
- More code info
- —