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CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total vol...

FDA Recall #D-1039-2023 — Class II — July 14, 2023

Recall #D-1039-2023 Date: July 14, 2023 Classification: Class II Status: Terminated

Product Description

CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1

Reason for Recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Recalling Firm

Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

84 bags

Distribution

Nationwide in the USA

Code Information

Lot: 36-254906, Exp. 7/22/2023.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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