Medroxyprogesterone acetate recall
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
Why was Medroxyprogesterone acetate recalled?
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 87100040
- 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
- Recalling firm
- Bayer HealthCare Pharmaceuticals Inc.
- Quantity
- 194.62 kg
- Distribution
- NY, CA
- Recall date
- July 24, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)