The Recall Desk
HighFDA (Drugs)·D-1117-2023·Announced 2023-09-06

Neonatal TPN Starter Bag Recalled Over Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 104 neonatal TPN starter bags (Lot 36-260022) due to lack of validation data for sanitization cycles, which could compromise sterility assurance in this IV medication.

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 a sterile injectable product for vulnerable neonatal patients where sterility assurance has not been validated. No illnesses or injuries have been reported. The hazard is preventive and precautionary in nature rather than confirmed contamination.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 104 bags of Neonatal TPN Starter Bag (Amino Acids 3%/Dextrose 5% with Calcium and Heparin, 250mL) with NDC 72196-0419-1. The affected lot is 36-260022, expiring August 19, 2023.

The recall was initiated because of lack of assurance of sterility resulting from lack of validation data for sanitization cycles. This means the manufacturer did not have adequate documented evidence that the sterilization processes used in manufacturing were effective and met required safety standards.

The product was distributed nationwide in the United States. Neonatal TPN bags are sterile injectable medications administered directly into patients' bloodstreams and require absolute sterility assurance to prevent life-threatening infections.

Healthcare facilities and pharmacies that received this product should discontinue use of affected bags from Lot 36-260022 immediately. Medical professionals should contact the manufacturer with any questions or if they have used this product.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition / Injectable
Hazard
  • sterility-assurance-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 (2)

  • Lot# 36-260022
  • Exp 8/19/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category