Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to failed sterility assurance after FDA inspection. 363 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 recall with no reported illnesses or injuries. Cardioplegia is a sterile injectable used in cardiac surgery, making sterility assurance critical to safety. The hazard is theoretical contamination pending investigation, with no illness reports to date.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, Induction 8:1 non-enriched (HIGH POTASSIUM, 70 mEq K), packaged in 300 mL bags. The recall affects 363 bags with lot numbers 37-894310, 37-895259, 37-898303, and 37-901367, with expiration dates ranging from April 29, 2023 to May 27, 2023. The product was distributed nationwide in the USA.
The recall was initiated after an FDA inspection called into question the sterility of the product. Cardioplegia solution is a sterile injectable medication used during cardiac surgery to protect the heart during cardiopulmonary bypass. Failure of sterility assurance poses a serious risk of microbial contamination.
Healthcare facilities and cardiac surgical teams that have received these lots should discontinue use immediately and contact Central Admixture Pharmacy Services, Inc. at 6580 Snowdrift Road, Allentown, PA 18106 for instructions on product return and replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-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 (8)
- Lot # 37-894310
- Exp 04/29/2023
- 37-895259
- Exp 05/04/2023
- 37-898303
- Exp 05/14/2023
- 37-901367
- Exp 05/27/2023
Distribution
Distributed nationwide across the United States.
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