CLASS IIDrug recall · Reported 6 Sep 2023 · FDA Enforcement Report
Neonatal TPN Starter, Amino Acids recalled by Central Admixture Pharmacy
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter, Amino Acids (trophamine) 4%/Dextrose 10% with Calcium and Heparin, distributed nationwide in the US. The recall was initiated on 17 Aug 2023 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLot# 36-260017, Exp 8/19/2023 ;
Quantity recalled108 bags
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Which lots are affected?
Lot# 36-260017, Exp 8/19/2023 ;
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.