May 2012 FDA Recall Drug by Bayer Healthcare Pharmaceuticals Inc.
D-1433-2012 - Cross Contamination w/Other Products

This Class II drug recall was voluntarily initiated by Bayer Healthcare Pharmaceuticals Inc. on May 8, 2012 for the product Drug. The FDA reported the reason for recall as cross contamination w/other products. The product was distributed in Kansas and California. and the recall is currently terminated.

Recall Number: D-1433-2012

Reason for Recall
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Initiated
05-08-2012
Reported
08-08-2012
Quantity
112.295 kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62651
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bayer HealthCare Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Kansas and California.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-18-2012
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot Number: 81202450, Exp 06/15/16