Product Detail

Product Description 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

Recall Number D-807-2013

Classification Class III

Code Info Lot 87100040

Product Distributed Qty 194.62 kg

Reason For Recall Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Event Detail

Event Id 65702

Product Type Drugs

Status Ongoing

Recalling Firm

Bayer HealthCare Pharmaceuticals Inc.
City Wayne

State NJ
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-06-13

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern NY, CA