Cardioplegia Solution recall: Sterility Concern
Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
Why was Cardioplegia Solution recalled?
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 37-893789, Exp 04/28/2023; 37-894318, Exp 04/29/2023; 37-895648, Exp 05/05/2023; 37-897301, Exp 05/12/2023; 37-898815, Exp 05/18/2023
- Product
- Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 329 bags
- Distribution
- Nationwide in the USA.
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)