FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 544 bags of Cardioplegia Solution distributed nationwide due to lack of sterility assurance identified during FDA inspection. No illnesses have been reported.
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 cardiac injection product due to lack of sterility assurance identified during FDA inspection. With no illnesses or injuries reported, this meets the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 8:1 High Potassium (NDC 71285-0102-1, 108 mEq K per 500 mL bag), due to lack of assurance of sterility. An FDA inspection raised concerns about whether the product, which is intended to be sterile, meets required sterility standards.
The recalled product was distributed nationwide in the United States. A total of 544 bags across multiple lot numbers were affected, with expiration dates between April and May 2023. The affected lot numbers include 37-894305, 37-896153, 37-897073, 37-897925, 37-897941, 37-899607, 37-899608, and 37-900320.
Cardioplegia solution is administered during cardiac surgery to induce temporary cardiac arrest and protect the heart during the operation. A lack of sterility assurance in this product presents a potential risk of infection or other complications for patients receiving it during surgical procedures.
No illnesses have been reported in connection with this recall as of the current announcement.
The recalled product
- Product
- Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Cardiac Surgery
- Hazard
- 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 (14)
- Lot # 37-894305
- Exp 04/29/2023
- 37-896153
- Exp 05/06/2023
- 37-897073
- Exp 05/11/2023
- 37-897925
- 37-897941
- Exp 05/13/2023
- 37-899607
- 37-899608
- Exp 05/20/2023
- 37-900320
- Exp 05/22/2023
Distribution
Distributed nationwide across the United States.
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