FDA Recall Terminated Historical recordClass II
Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1.
- Reason
- Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
- Published
- May 31, 2023
- Distribution
- Nationwide
