Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 128

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.

Part of a larger recall action

This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · lack of sterility