The Recall Desk
HighFDA (Drugs)·D-1116-2023·Announced 2023-09-06

Neonatal TPN IV bags recalled due to lack of sterility validation

Central Admixture Pharmacy Services is recalling 200 neonatal TPN IV bags (lots 36-262872 and 36-262873, expiring 8/27/2023) distributed nationwide due to lack of validated sanitization procedures.

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 for a parenteral nutrition product lacking validated sterilization procedures. The hazard represents potential microbial contamination that could pose serious risk to critically ill neonatal patients. No illnesses or injuries have been reported. Under the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in High severity.

Plain-English summary

Central Admixture Pharmacy Services, Inc., located in Phoenix, Arizona, is recalling Neonatal TPN Starter Bag, which contains Amino Acids (Trophamine) 3.5% and Dextrose 10%. The product is supplied as a 250 mL intravenous bag for prescription use only. The affected lot numbers are 36-262872 and 36-262873, both with an expiration date of August 27, 2023. Approximately 200 units were distributed.

The recall was issued due to lack of assurance of sterility. The specific concern is the lack of validation data for the sanitization cycles used in manufacturing. Without adequate validation, there is no documented assurance that the sterilization process reliably achieves the sterile conditions necessary for safe intravenous use.

This product is intended for neonatal patients requiring parenteral nutrition support and is used in hospital clinical settings. The recall applies to product distributed nationwide in the United States.

The recalled product

Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Parenteral Nutrition / IV Admixture
Hazard
  • sterility-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 (3)

  • Lot# 36-262872
  • 36-262873
  • Exp 8/27/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category