The Recall Desk
HighFDA (Drugs)·D-0673-2023·Announced 2023-05-31

Cardioplegia Solution Recall Due to Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of assurance of sterility. An FDA inspection raised concerns about whether the 329 bags were properly sterilized.

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 classified this as a Class II recall. No illnesses or injuries have been reported in the source material. Per the severity rubric, a Class II recall without reported hospitalization or adverse events, where the sterility concern is theoretical, scores as High (3).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 329 bags of Cardioplegia Solution, Modified St Thomas Formula (HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL bags, NDC 71285-0209-1, Rx only) due to lack of assurance of sterility. An FDA inspection raised questions about whether these products, which are intended to be sterile, were properly sterilized.

The affected product was distributed nationwide in the USA under the following lot numbers: 37-893789 (Exp 04/28/2023), 37-894318 (Exp 04/29/2023), 37-895648 (Exp 05/05/2023), 37-897301 (Exp 05/12/2023), and 37-898815 (Exp 05/18/2023).

Healthcare providers and patients should not use the recalled product without contacting the manufacturer or their healthcare provider. Those with questions should contact Central Admixture Pharmacy Services, Inc. in Allentown, PA for additional information.

The recalled product

Product
Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
  • sterilization-failure
  • 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 (10)

  • Lot # 37-893789
  • Exp 04/28/2023
  • 37-894318
  • Exp 04/29/2023
  • 37-895648
  • Exp 05/05/2023
  • 37-897301
  • Exp 05/12/2023
  • 37-898815
  • Exp 05/18/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category