FDAClass IIAugust 8, 2012

Estradiol Hemihydrate M20 EP/USP Powder recall: Contamination

Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.

Why was Estradiol Hemihydrate M20 EP/USP Powder recalled?

Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.

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 Number: 81202450, Exp 06/15/16

Product
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
Recalling firm
Bayer HealthCare Pharmaceuticals Inc.
Quantity
112.295 kg
Distribution
Kansas and California.
Recall date
August 8, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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