The Recall Desk
HighFDA (Drugs)·D-1011-2023·Announced 2023-08-09

Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were distributed nationwide.

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 of a neonatal IV nutrition product with lack of sterility assurance and missing validation data for decontamination cycles. While no illnesses or injuries have been reported, this is a risk-of-harm product where vulnerable neonatal patients are at high risk from potential contamination.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 420 neonatal TPN Starter Bags (Amino Acids 4%/Dextrose 10% with Calcium and Heparin, 250mL IV bags) due to lack of assurance of sterility. The FDA identified that validation data for decontamination cycles was lacking, which means the manufacturer cannot guarantee the products are sterile.

The recalled lots include: Lot 36-251208 (Exp. 7/10/2023), Lot 36-252137 (Exp. 7/16/2023), Lots 36-254920 and 36-254926 (Exp. 7/22/2023), and Lot 36-256529 (Exp. 7/29/2023). These products were distributed nationwide in the United States.

Neonatal patients are at risk from non-sterile IV nutrition products, as contamination could lead to serious infections. Healthcare facilities that received these products should stop using them immediately and contact the manufacturer or the FDA for further guidance.

The recalled product

Product
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
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Neonatal IV Nutrition
Hazard
  • sterility-assurance-failure
  • validation-failure
  • 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 (9)

  • Lot: 36-251208
  • Exp. 7/10/2023
  • 36-252137
  • Exp. 7/16/2023
  • 36-254920
  • 36-254926
  • Exp. 7/22/2023
  • 36-256529
  • Exp. 7/29/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category