The Recall Desk
HighFDA (Drugs)·D-1122-2023·Announced 2023-09-06

Neonatal TPN Nutrition Bags Recalled for Sterility Validation Deficiency

Central Admixture Pharmacy Services recalled 108 bags of neonatal TPN solution (Lot 36-260017, expires 8/19/2023) due to insufficient validation data for sterilization cycles. The product was 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: This is an FDA Class II recall of a parenteral nutrition product with no reported illnesses or injuries. The lack of validated sterilization procedures for a drug used in vulnerable neonatal patients constitutes a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 108 bags of Neonatal TPN Starter Bag containing Amino Acids (trophamine) 4%, Dextrose 10%, with Calcium and Heparin. The product is a 250 mL intravenous solution (NDC: 72196-0422-1) distributed nationwide. The recalled lot is 36-260017, with an expiration date of August 19, 2023.

The recall was initiated because the manufacturer lacks validation data for the sanitization cycles used in the manufacturing process. Without documented validation of these sterilization procedures, there is no assurance that the product meets sterility standards required for parenteral medications.

Neonatal TPN (Total Parenteral Nutrition) solutions are used to provide essential intravenous nutrition to newborns. Because neonates are immunologically vulnerable, any lack of sterility assurance in these products represents a potential risk.

Healthcare providers and patients who have received bags from lot 36-260017 should contact Central Admixture Pharmacy Services or their healthcare provider immediately regarding this recall. Affected product should not be used.

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 — Parenteral Nutrition
Hazard
  • lack-of-sterility
  • contamination

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# 36-260017
  • Exp 8/19/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category