PlainRecalls
FDA Drug Moderate Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1

Reported: September 6, 2023 Initiated: August 17, 2023 #D-1115-2023

Product Description

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1

Reason for Recall

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Details

Units Affected
40 bags
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 40 bags.
Why was this product recalled?
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Which agency issued this recall?
This recall was issued by the FDA Drug on September 6, 2023. Severity: Moderate. Recall number: D-1115-2023.