FDAFDA · Food and drugs·Recall number D-0679-2023
Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
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 # 37-895694, 37-896050, Exp 05/05/2023; 37-898304, Exp 05/14/2023; 37-899234, Exp 05/19/2023; 37-901375, Exp 05/27/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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