Agency classClass IIOur severity:High FDA (Drugs)·D-1007-2023·Announced 2023-08-09

Neonatal TPN Starter Bag Recalled Due to Sterility Assurance Issues

Central Admixture Pharmacy Services is recalling a neonatal IV nutrition bag due to lack of sterility assurance. The recall affects 156 bags of the product distributed nationwide.

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 is an FDA Class II recall of a neonatal parenteral nutrition product. While no illnesses have been reported, the defect—lack of assurance of sterility in a critical care product for vulnerable newborns—constitutes a risk-of-harm scenario meeting the High severity threshold.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bag (Amino Acids 3.5% / Dextrose 10% with Calcium, 250 mL) with NDC 72196-0407-1 due to lack of assurance of sterility. Validation data for decontamination cycles is lacking.

The affected lot is 36-251206 with an expiration date of July 10, 2023. A total of 156 bags were distributed nationwide.

Neonatal TPN bags are critical care products used for intravenous nutrition in newborns. Lack of sterility assurance poses a potential risk of infection in this vulnerable population. No illnesses have been reported to date.

Healthcare providers who received this product should contact Central Admixture Pharmacy Services, Inc. or the FDA for guidance on appropriate actions regarding the recalled lot.

The recalled product

Product: Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043,NDC: 72196-0407-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Parenteral Nutrition / IV Admixture
Hazard: lack-of-sterility
infection-risk
Affected units: 156

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: 36-251206
Exp. 7/10/2023.

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