Heart Surgery Solutions Recalled

Central Admixture Pharmacy Services Inc is recalling a multitude of microplegia and cardioplegia solution products due to a lack of assurance of sterility. According to the May 31, 2023, US Food and Drug Administration (FDA) Enforcement Report, an FDA inspection called into question the sterility of the products.

The recall affects the following products, which were distributed throughout the United States by Central Admixture Pharmacy Services, Allentown, Pennsylvania:

• microplegia (MSA/MSG .92 molar), packaged in 125 mL per bag (NDC 71285-0001-1);
• cardioplegia solution, warm induction 4:1 high potassium (40 mEq) packaged in 500 mL per bag (NDC 71285-0002-1);
• microplegia solution, MSA/MSG .92 molar with CP2D, packaged in 120 mL per bag (NDC 71285-0012-2);
• microplegia solution, high potassium (100 mEq), packaged in 200 mL per bag (NDC 71285-0213-1); 
• modified Del Nido microplegia, packaged in 40 mL per syringe (NDC 71285-0219-1);
• cardioplegia solution, reperfusate no potassium, packaged in 238.75 mL per bag (NDC 71285-0005-1);
• cardioplegia solution, reperfusate no potassium, packaged in 477.5 mL per bag (NDC 71285-0006-1);
• cardioplegia solution, reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag (NDC 71285-0007-1);
• cardioplegia solution, reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag (NDC 71285-0008-1);
• cardioplegia solution, reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag (NDC 71285-0009-1);
• cardioplegia solution, warm induction 4:1 high potassium/low tromethamine, 40 mEq K, packaged in 500 mL per bag (NDC 71285-0011-1);
• cardioplegia solution, induction 4:1, high potassium, 60 mEq K, packaged in 830 mL per bag (NDC 71285-0100-1);
• cardioplegia solution, induction 4:1, high potassium/low tromethamine, 36 mEq K, packaged in 500 mL per bag (NDC 71285-0101-1);
• cardioplegia solution, induction 8:1 high potassium, 108 mEq K, packaged in 500 mL per bag (NDC 71285-0102-1);
• cardioplegia solution, maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag (NDC 71285-0103-1);
• cardioplegia solution, maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag (NDC 71285-0104-1);
• cardioplegia solution, induction 4:1 high potassium, 30 mEq K, packaged in 415 mL per bag (NDC 71285-0106-1);
• cardioplegia solution, induction 8:1 high potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag (NDC 71285-0107-1);
• cardioplegia solution, maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag (NDC 71285-0105-1);
• cardioplegia solution, induction 4:1 Plasma-lyte/tromethamine, high potassium, packaged in 500 mL per bag (NDC 71285-0111-1);
• cardioplegia solution, maintenance 4:1 Plasma-lyte/tromethamine, low potassium, packaged in 1000 mL per bag (NDC 71285-0112-1);
• cardioplegia solution, Del Nido formula, packaged in 1052.8 mL per bag (NDC 71285-0202-1);
• cardioplegia solution, modified St. Thomas solution, low potassium, high sodium bicarbonate, 62 mEq K, packaged in 1000 mL per bag (NDC 71285-0203-1);
• cardioplegia solution, modified St. Thomas solution, high potassium, high sodium bicarbonate, 106 mEq K (NDC 71285-0204-1);
• cardioplegia solution, maintenance 4:1 in Ringer’s, low potassium, 12 mEq K, packaged in 504.8 mL per bag (NDC 71285-0205-1);
• cardioplegia solution, induction 4:1 in Ringer’s, high potassium, 48 mEq K, packaged in 522.8 mL per bag (NDC 71285-0206-1);
• cardioplegia solution, modified St. Thomas formula, low potassium, 70 mEq K, packaged in 1000 mL per bag (NDC 71285-0210-1);
• cardioplegia solution, modified St. Thomas formula, high potassium, 122 mEq K, packaged in 1000 mL per bag (NDC 71285-0209-1);
• cardioplegia solution, maintenance 4:1 Plasma-lyte, low potassium, low K, packaged in 1047 mL per bag (NDC 71285-0211-1);
• cardioplegia solution, induction 4:1 Plasma-lyte, high potassium, high k, packaged in 542 mL per bag (NDC 71285-0212-1);
• cardioplegia solution, induction 8:1 non-enriched, high potassium, 70 mEq K, packaged in 300 mL per bag (NDC 71285-0214-1);
• cardioplegia solution, maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag (NDC 71285-0215-1); and
• cardioplegia solution, Leesburg Cardioplegia, packaged in 1030.2 mL per bag (NDC 71285-0218-1).

The FDA Enforcement Report includes details for each recalled solution, including lot numbers and expiration dates.

Central Admixture Pharmacy Services voluntarily initiated the recalls April 28, 2023. On May 19, 2023, the FDA designated them Class II. Per the classification, use of the recalled products may cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Microplegia and cardioplegia solutions are used during cardiac surgery.