FDARecalled May 31, 2023 · #D-0674-2023
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Alle...
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, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
- Type
- Drugs
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Model numbers
- 37-894320
- UPCs
- —