D-1119-2023 Class II Terminated
FDA drug recall D-1119-2023 was initiated by Central Admixture Pharmacy Services, Inc. on August 17, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles The recall status is terminated (terminated March 27, 2025). Affected quantity: 136 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- September 6, 2023
- Initiation Date
- August 17, 2023
- Termination Date
- March 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 bags
Product Description
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 36-262160, 36-262146, Exp 8/21/2023 ;