Why it was recalled
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Product description
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
Lot numbers, UPCs & expiration codes
B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12
Where it was sold
Nationwide
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-156-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 31, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 138,505 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer HealthCare Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-156-2013, exactly as published.
Show all FDA fields
- City
- Lynnwood
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 62908
- Address
- 2625 162nd St SW
- Code information
- B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12
- Postal code
- 98087
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-156-2013
- Classification
- Class III
- Recalling firm
- Bayer HealthCare Pharmaceuticals Inc.
- Product quantity
- 138,505 vials
- Termination date
- May 10, 2013
- Reason for recall
- Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
- Distribution pattern
- Nationwide
- Recall initiation date
- May 31, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 7, 2013