Central Admixture Pharmacy Services, Inc.: Drug Recall

Recall #D-0956-2023 · 07/14/2023

Class II: Risk

Recall Details

Recall Number: D-0956-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Central Admixture Pharmacy Services, Inc.
Status: Terminated
Date Initiated: 07/14/2023
Location: Phoenix, AZ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,480 bags

Reason for Recall

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

Product Description

Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1

Distribution Pattern

Nationwide in the USA

Other Recalls by Central Admixture Pharmacy Services, Inc.

Class I: Dangerous 02/20/2025

Presence of Particulate Matter
Class II: Risk 09/21/2023

Lack of assurance of sterility:
Class II: Risk 09/21/2023

Lack of assurance of sterility:
Class II: Risk 09/21/2023

Lack of assurance of sterility:
Class II: Risk 09/21/2023

Lack of assurance of sterility:

View all recalls by Central Admixture Pharmacy Services, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.