D-0951-2023 Class II Terminated

Recalled by Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Recall Details

Product Type
Drugs
Report Date
August 9, 2023
Initiation Date
July 14, 2023
Termination Date
March 28, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,260 bags

Product Description

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 36-243946, 36-243947, 36-243948, 36-243949, Exp. 7/11/2023; 36-255120, Exp. 8/17/2023; 36-246829, 36-246831, 36-246832, Exp. 7/18/2023; 36-255961, Exp. 8/21/2023; 36-256896, Exp. 8/25/2023.