The Recall Desk
HighFDA (Drugs)·D-1009-2023·Announced 2023-08-09

Neonatal TPN starter bags recalled for lack of sterility assurance

Central Admixture Pharmacy Services is recalling 244 neonatal TPN IV bags due to lack of assurance that the sterility process was validated. The manufacturer lacked adequate validation data for their decontamination cycles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving lack of sterility assurance in an injectable neonatal product. No illnesses or injuries reported in the source; the hazard is theoretical contamination risk in a high-risk product category.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 244 neonatal TPN (total parenteral nutrition) starter bags nationwide. The recalled product is a sterile injectable formulation containing 3.5% amino acids (trophamine), 10% dextrose, and heparin in a 250 mL IV bag. The product is a prescription medication (NDC 72196-0431-1) manufactured for use in neonatal patients.

The recall was issued due to lack of assurance of sterility. The FDA determined that validation data for decontamination cycles was lacking, meaning the manufacturer could not adequately demonstrate that their sterilization processes were effective. This raises a potential risk of microbial contamination in these injectable products.

Affected lot numbers are 36-251452 (expiration 7/14/2023) and 36-254918 (expiration 7/22/2023). The product was distributed nationwide in the United States.

Patients and healthcare providers who have these products should not use them. Contact the manufacturer or distributor for instructions on product return or replacement. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Neonatal Injectable
Hazard
  • lack-of-sterility
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot: 36-251452
  • Exp. 7/14/2023
  • 36-254918
  • Exp. 7/22/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category