Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot # 37-895647, Exp 05/05/2023; 37-898310, Exp 05/14/2023; 37-899622, Exp 05/20/2023; 37-900951, Exp 05/26/2023
  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, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.

Product Codes/Lot Numbers:

Lot # 37-895647, Exp 05/05/2023; 37-898310, Exp 05/14/2023; 37-899622, Exp 05/20/2023; 37-900951, Exp 05/26/2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0659-2023

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