The Recall Desk
HighFDA (Drugs)·D-0985-2023·Announced 2023-08-09

Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services recalls 128 neonatal TPN starter bags distributed nationwide due to lacking validation of decontamination procedures, creating inability to assure product sterility.

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: This FDA Class II recall involves lack of sterility assurance in a neonatal intravenous admixture product, which represents a risk-of-harm scenario for a vulnerable patient population. No illnesses, injuries, or confirmed contamination have been reported; the hazard is theoretical based on the manufacturer's inability to validate adequate decontamination procedures.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 128 neonatal TPN (Total Parenteral Nutrition) starter bags distributed nationwide. The recalled product is a 250mL IV bag containing Amino Acids (trophamine) 2% and Dextrose 10%.

The recall is due to a lack of assurance of sterility. Validation data for the decontamination cycles is lacking, which means the manufacturer cannot confirm that its sterilization process is adequate to ensure product sterility.

This product is used for intravenous administration to neonatal (newborn) patients. The affected lot numbers are 36-251458 (Exp. 7/14/2023), 36-251695 (Exp. 7/15/2023), and 36-256027 (Exp. 7/28/2023), with NDC 72196-0400-1.

Healthcare facilities and pharmacies that received these bags should discontinue use and quarantine any remaining product. Contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043 for recall and return procedures.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0400-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Neonatal IV Admixture
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 (6)

  • Lot: 36-251458
  • Exp. 7/14/2023
  • 36-251695
  • Exp. 7/15/2023
  • 36-256027
  • Exp. 7/28/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category