Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mE...
FDA Recall #D-0669-2023 — Class II — April 28, 2023
Product Description
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
182 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-894704, Exp 04/30/2023; 37-896126, Exp 05/06/2023; 37-898276, Exp 05/14/2023; 37-899141, Exp 05/19/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated