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Class II: temporary or reversible health riskTerminated

Bayer HealthCare Pharmaceuticals Estradiol Hemihydrate M20 EP/ Powder Recall

Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1

Bayer HealthCare Pharmaceuticals Inc. · Wayne, NJ

Risk level
Class II
Reported by FDA
Aug 8, 2012
Recall ID
D-1433-2012
Check your lot numberHow we source this data

Summary

Bayer HealthCare Pharmaceuticals recalled Estradiol Hemihydrate M20 EP/ Powder starting May 8, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1433-2012 on Aug 8, 2012. Reason: Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. Status: Terminated.

Why it was recalled

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

Product description

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.

Lot numbers, UPCs & expiration codes

Lot Number: 81202450, Exp 06/15/16

Where it was sold

Kansas and California.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1433-2012
Classification
Class II
Status
Terminated
Recall initiated
May 8, 2012
FDA report date
Aug 8, 2012
Quantity
112.295 kg
Recall type
Voluntary: Firm initiated
Recalling firm
Bayer HealthCare Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-1433-2012, exactly as published.

Show all FDA fields
City
Wayne
State
NJ
Status
Terminated
Country
United States
Event ID
62651
Address
6 W Belt Plz
Code information
Lot Number: 81202450, Exp 06/15/16
Postal code
07470
Report date
Aug 8, 2012
Product type
Drugs
Recall number
D-1433-2012
Classification
Class II
Recalling firm
Bayer HealthCare Pharmaceuticals Inc.
Product quantity
112.295 kg
Termination date
Dec 18, 2012
Reason for recall
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Kansas and California.
Recall initiation date
May 8, 2012
Initial firm notification
Letter
Center classification date
Jul 31, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1433-2012, published Aug 8, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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