FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.
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 for lack of sterility assurance in an injectable pharmaceutical product due to inadequate validation of sterilization processes. This qualifies as a risk-of-harm product where injury has not been reported, matching the rubric criterion for High severity.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 304 bags of Cardioplegia Solution (20 mEq K, Maintenance 4:1, Low Potassium, 810 mL EVA bags, NDC 72196-0103-1) distributed nationwide.
The recall was issued because the manufacturer lacks validation data for sanitization cycles. This means there is no documented assurance that the product's sterilization process is adequate. Sterilization is critical for injectable pharmaceutical products.
Affected lot numbers are 36-262315 (expires 8/21/2023), 36-262514 (expires 8/25/2023), and 36-262993 (expires 8/28/2023). Healthcare facilities that have received this product should stop using it immediately, quarantine remaining supplies, and contact Central Admixture Pharmacy Services for return or disposal instructions.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / Cardiac
- Hazard
- lack-of-sterility
- sterilization-validation
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 (6)
- Lot# 36-262315
- Exp 8/21/2023
- 36-262514
- Exp 8/25/2023
- 36-262993
- Exp 8/28/2023.
Distribution
Distributed nationwide across the United States.
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