The Recall Desk
HighFDA (Drugs)·D-1021-2023·Announced 2023-08-09

Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.

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: FDA Class II recall of a sterile injectable due to unverified sterilization processes with lack of sterility assurance. No reported illnesses, injuries, or deaths. Classified as High because it involves a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag (NDC 72196-0217-1) distributed nationwide in the USA. The recalled product includes Lot 36-253947, which expires 7/20/2023. A total of 44 bags have been identified in this recall.

The recall was initiated due to lack of assurance of sterility and insufficient validation data for decontamination cycles. This means the sterilization process used for this product cannot be verified as adequate, creating a potential risk of microbial contamination in this sterile injectable solution.

Healthcare facilities that received this product should immediately discontinue use of the affected lot and secure it appropriately. Facilities should consult with Central Admixture Pharmacy Services, Inc. regarding proper disposal procedures and determine whether patient notification is necessary based on product exposure and individual clinical status.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
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:36-253947
  • Exp. 7/20/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category