FDAFDA · Food and drugs·Recall number D-0658-2023
Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1.
Published May 31, 2023 · Recall initiated: April 28, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Distributor
- Nationwide in the USA.
- Lot
- Lot # 37-894304, Exp 04/29/2023; 37-894946, Exp 05/01/2023; 37-896482, Exp 05/07/2023; 37-897933, Exp 05/13/2023; 37-900461, Exp 05/22/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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