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CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarb...

FDA Recall #D-1029-2023 — Class II — July 14, 2023

Recall #D-1029-2023 Date: July 14, 2023 Classification: Class II Status: Terminated

Product Description

CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1

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

144 bags.

Distribution

Nationwide in the USA

Code Information

Lot:36-253949, Exp. 7/20/2023; 36-255411, Exp. 7/23/2023.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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