Agency classClass IIOur severity:High FDA (Drugs)·D-1009-2023·Announced 2023-08-09

Neonatal TPN starter bags recalled for lack of sterility assurance

Central Admixture Pharmacy Services is recalling 244 neonatal TPN IV bags due to lack of assurance that the sterility process was validated. The manufacturer lacked adequate validation data for their decontamination cycles.

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: FDA Class II recall involving lack of sterility assurance in an injectable neonatal product. No illnesses or injuries reported in the source; the hazard is theoretical contamination risk in a high-risk product category.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 244 neonatal TPN (total parenteral nutrition) starter bags nationwide. The recalled product is a sterile injectable formulation containing 3.5% amino acids (trophamine), 10% dextrose, and heparin in a 250 mL IV bag. The product is a prescription medication (NDC 72196-0431-1) manufactured for use in neonatal patients.

The recall was issued due to lack of assurance of sterility. The FDA determined that validation data for decontamination cycles was lacking, meaning the manufacturer could not adequately demonstrate that their sterilization processes were effective. This raises a potential risk of microbial contamination in these injectable products.

Affected lot numbers are 36-251452 (expiration 7/14/2023) and 36-254918 (expiration 7/22/2023). The product was distributed nationwide in the United States.

Patients and healthcare providers who have these products should not use them. Contact the manufacturer or distributor for instructions on product return or replacement. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Neonatal Injectable
Hazard: lack-of-sterility
contamination-risk
Affected units: 244

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 (4)

Lot: 36-251452
Exp. 7/14/2023
36-254918
Exp. 7/22/2023.

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