Neonatal TPN Starter Bag Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 71 bags of Neonatal TPN Starter Bag nationwide following an FDA inspection that questioned the product's sterility. The affected lots expire in April and May 2023.
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 of a sterile product with unconfirmed sterility for vulnerable neonatal patients. No illnesses or injuries reported. Per the severity rubric, products posing risk-of-harm without reported injury score High (3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 71 bags of Neonatal TPN Starter Bag containing Amino Acids (Trophamine) 3.5% and Dextrose 10% in 250 mL bags. The recalled product was distributed nationwide throughout the United States.
The recall was initiated after an FDA inspection raised questions about whether the manufacturer could provide adequate assurance that the product met sterility requirements. Because this product is intended to be administered intravenously to neonatal patients, sterility is a critical quality attribute.
The affected lot numbers are 37-894328 (expiration date 04/29/2023) and 37-897792 (expiration date 05/12/2023). All recalled units were distributed nationwide.
Healthcare institutions should identify and secure any inventory matching the recalled lot numbers.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Hazard
- Affected units
- 71
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 # 37-894328
- Exp 04/29/2023
- 37-897792
- Exp 05/12/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 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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