The Recall Desk
HighFDA (Drugs)·D-0654-2023·Announced 2023-05-31

FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags 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: FDA Class II sterility assurance recall affecting an injectable pharmaceutical with no reported illnesses or injuries. While lack of sterility assurance in a cardiac surgical drug presents significant patient safety risk, the actual hazard is theoretical.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Reperfusate 4:1 (NDC 71285-0009-1) due to lack of assurance of sterility. An FDA inspection called into question whether the product met sterility requirements for its intended use.

Four affected lots totaling 254 bags have been distributed nationwide: Lot 37-893848 (expires 04/28/2023), Lot 37-895681 (expires 05/05/2023), Lot 37-899250 (expires 05/19/2023), and Lot 37-901355 (expires 05/27/2023). The manufacturer is Central Admixture Pharmacy Services, Inc., located in Allentown, Pennsylvania.

Microbial contamination of a sterile injectable pharmaceutical could pose serious risks to patient health. No illnesses or injuries related to this recall have been reported.

Healthcare providers and patients using the affected lots should discontinue use immediately and contact the manufacturer or FDA for instructions regarding product return or disposal.

The recalled product

Product
Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug
Hazard
  • sterility-assurance
  • 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 (8)

  • Lot # 37-893848
  • Exp 04/28/2023
  • 37-895681
  • Exp 05/05/2023
  • 37-899250
  • Exp 05/19/2023
  • 37-901355
  • Exp 05/27/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category