D-1000-2023 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
516 bags

Product Description

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 36-251200, 36-251209, Exp. 7/10/2023; 36-252140, Exp. 7/16/2023; 36-256334, 36-256335, Exp. 7/29/2023.