The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0670-2023·Announced 2023-05-31

Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution for lack of assurance of sterility. FDA inspection questioned the sterility of this injectable product; 241 bags were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA Class II recall concerns a sterile injectable product used in cardiac surgery. While no illnesses or injuries have been reported, the lack of sterility assurance in an injectable surgical product represents a high-risk scenario with potential for serious harm. The score reflects a high-risk product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution (Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K) in 1000 mL bags due to lack of assurance of sterility.

The recall was initiated after an FDA inspection called into question whether this sterile injectable product met required sterility standards. Cardioplegia solution is an injectable fluid used during cardiac surgery to protect the heart. If sterility cannot be assured, the product poses a potential risk of infection to patients undergoing cardiac procedures.

The recalled product includes 241 bags distributed nationwide. Affected lot numbers are: 37-894705 (Exp 04/30/2023), 37-896127 (Exp 05/06/2023), 37-898278 (Exp 05/14/2023), 37-899148 (Exp 05/19/2023), and 37-900619 (Exp 05/25/2023).

Healthcare providers who received this product should discontinue use of the affected lots and consult with their physician or pharmacist regarding appropriate action. Patients who have received this product during cardiac surgery should consult with their healthcare provider if they have concerns.

The recalled product

Product
Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug
Hazard
Affected units
241

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 # 37-894705
  • Exp 04/30/2023
  • 37-896127
  • Exp 05/06/2023
  • 37-898278
  • Exp 05/14/2023
  • 37-899148
  • Exp 05/19/2023
  • 37-900619
  • Exp 05/25/2023

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 →

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