Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot # 37-894300, Exp 04/29/2023; 37-896114, Exp 05/06/2023; 37-896417, Exp 05/07/2023; 37-897388, Exp 05/12/2023; 37-898798, Exp 05/18/2023; 37-899618, Exp 05/20/2023
  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:
Central Admixture Pharmacy Services, Inc.
Reason for Recall:
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.

Product Codes/Lot Numbers:

Lot # 37-894300, Exp 04/29/2023; 37-896114, Exp 05/06/2023; 37-896417, Exp 05/07/2023; 37-897388, Exp 05/12/2023; 37-898798, Exp 05/18/2023; 37-899618, Exp 05/20/2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0667-2023

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