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.
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 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
- Affected units
- 108
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.
Part of a larger recall action
This product is one of 32 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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