The Recall Desk
HighFDA (Drugs)·D-1023-2023·Announced 2023-08-09

Cardioplegia Solution recalled for lack of sterility assurance

Central Admixture Pharmacy Services is recalling 56 bags of Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination cycles. Product was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile pharmaceutical used in cardiac surgery, where any contamination poses significant risk. However, no deaths, illnesses, or injuries have been reported, and the hazard remains theoretical pending contamination confirmation.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, 7.5 mEq K, Reperfusate 4:1 in IV bags (NDC 72196-0007-1). This is a compounded medication used during cardiac surgery procedures.

The recall was initiated due to lack of assurance of sterility in the product. The manufacturer's validation data for decontamination cycles was not adequate, creating a potential for contamination.

Fifty-six bags of the recalled product were distributed nationwide, with lot number 36-252143 and an expiration date of July 2023. This product is prescribed and administered only in hospital settings by healthcare professionals.

Healthcare facilities that may have received this product should immediately quarantine and destroy any unused product from the affected lot and contact the manufacturer. Patients who received this product during cardiac surgery procedures need not take action, as the medication was administered before the recall was issued.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Compounded Injectables
Hazard
  • lack-of-sterility
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 36-252143
  • Exp. 7/20/2023.

Distribution

Distributed nationwide across the United States.

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