June 2013 FDA Recall Drug by Bayer Healthcare Pharmaceuticals Inc.
D-807-2013 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Bayer Healthcare Pharmaceuticals Inc. on June 13, 2013 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed in NY, CA and the recall is currently terminated.

Recall Number: D-807-2013

Reason for Recall
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Initiated
06-13-2013
Reported
07-24-2013
Quantity
194.62 kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65702
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
NY, CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2014
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin

Batch or Lot Expiration Information

Lot# Lot 87100040