Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Defect
Central Admixture Pharmacy Services is recalling 188 neonatal TPN bags nationwide because sterility assurance cannot be guaranteed. Validation data for decontamination cycles is lacking.
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 with no reported illnesses or injuries. The deficiency in sterility assurance represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High (score 3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling neonatal TPN (Total Parenteral Nutrition) Starter Bags distributed nationwide. The product is a 250mL IV bag containing amino acids (trophamine) 2%, dextrose 10%, calcium, and heparin. Affected lots are 36-254909 (expiration 7/22/2023) and 36-256333 (expiration 7/29/2023).
The manufacturer is recalling the product due to lack of assurance of sterility. Specifically, validation data for the decontamination cycles used in product preparation is lacking. This deficiency prevents confirmation that the product has been properly sterilized.
Neonatal TPN is a critical medication for newborns who cannot receive nutrition by mouth. The sterility of injectable medications is essential to patient safety.
Healthcare facilities and pharmacies that have received the affected lots should verify their inventory using the lot numbers and expiration dates provided. Any remaining recalled product should be handled in accordance with manufacturer and regulatory guidance.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0416-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 188
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: 36-254909
- Exp. 7/22/2023
- 36-256333
- Exp. 7/29/2023.
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.
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