Reported Jul 24, 2013 · Terminated
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums…
Bayer HealthCare Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer HealthCare Pharmaceuticals Inc. · 36 Columbia Rd · Morristown, NJ · 07960-4526
Is this the product you have?
- 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
- Lot codes and dates
- Lot 87100040
- Amount recalled
- 194.62 kg
Where it was sold
Why it was recalled
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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