FDARecalled May 31, 2023 · #D-0654-2023
Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, ...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Classification: Class II Distribution: Nationwide in the USA.
Product details
- Product
- Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
- Type
- Drugs
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Model numbers
- 37-893848
- UPCs
- —