The Recall Desk
HighFDA (Drugs)·D-1033-2023·Announced 2023-08-09

Cardioplegia Solution Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services has recalled 80 bags of Cardioplegia Solution (NDC 72196-0210-1) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.

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 with no reported illnesses or injuries. While sterility defects in injectable medications represent significant risk of harm, the absence of reported incidents places this at High rather than Severe per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 80 bags of Cardioplegia Solution (70 mEq K, Modified St. Thomas Formula low potassium), supplied as IV bags of 1000 mL total volume (NDC 72196-0210-1). The affected lot is 36-255214 with expiration date July 23, 2023. The product was distributed nationwide in the United States.

The recall was issued due to lack of assurance of sterility. The manufacturer did not provide validation data for decontamination cycles, creating a deficiency in the ability to confirm that the product meets sterility standards required for injectable medications.

Further information may be obtained from the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls using recall number D-1033-2023.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous
Hazard
  • sterility-defect
  • 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:36-255214
  • Exp.7/23/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category