Why it was recalled
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
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
Lot numbers, UPCs & expiration codes
Lot 87100040
Where it was sold
NY, CA
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-807-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 13, 2013
- FDA report date
- Jul 24, 2013
- Quantity
- 194.62 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer HealthCare Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-807-2013, exactly as published.
Show all FDA fields
- City
- Morristown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65702
- Address
- 36 Columbia Rd
- Code information
- Lot 87100040
- Postal code
- 07960-4526
- Report date
- Jul 24, 2013
- Product type
- Drugs
- Recall number
- D-807-2013
- Classification
- Class III
- Recalling firm
- Bayer HealthCare Pharmaceuticals Inc.
- Product quantity
- 194.62 kg
- Termination date
- Feb 10, 2014
- Reason for recall
- Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- NY, CA
- Recall initiation date
- Jun 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 18, 2013