🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: May 31, 2012 Bayer HealthCare Pharmaceuticals Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bayer HealthCare Pharmaceuticals Inc.
Reason for Recall:
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-156-2013

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