Drug Enforcement D-807-2013

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

Status

Terminated

Classification

Class III

Report Date

July 24, 2013

Termination Date

February 10, 2014

Product Information

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
Product quantity
194.62 kg
Reason for recall
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
NY, CA

Location & Firm

Recalling firm
Bayer Healthcare Pharmaceuticals Inc.
Address
36 Columbia Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-807-2013
Event ID
65702
Recall initiation date
June 13, 2013
Center classification date
July 18, 2013
Code info
Lot 87100040
More code info
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