The Recall Desk
HighFDA (Drugs)·D-0674-2023·Announced 2023-05-31

Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.

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 injectable product due to sterility assurance concerns identified by FDA inspection, creating risk of infection. No illnesses, injuries, or deaths have been reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 208 bags of its Cardioplegia Solution, Modified St Thomas Formula, low potassium, packaged in 1000 mL per bag. The recall was initiated after an FDA inspection raised concerns about the sterility assurance of the product.

The product was distributed nationwide in the United States. The affected lot numbers are 37-894320 (expiration 04/29/2023), 37-894324 (expiration 04/29/2023), 37-897297 (expiration 05/12/2023), and 37-898509 (expiration 05/15/2023). This is a prescription-only sterile injectable solution.

Healthcare facilities should verify whether they have the affected product in inventory. Patients who received this product should consult their healthcare provider regarding this recall.

The recalled product

Product
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Cardioplegia Solution
Hazard
Affected units
208

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 (7)

  • Lot # 37-894320
  • Exp 04/29/2023
  • 37-894324
  • 37-897297
  • Exp 05/12/2023
  • 37-898509
  • Exp 05/15/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 108 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility assurance

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