Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags after FDA inspection questioned whether these injectable products maintain required sterility standards.
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 pharmaceutical where FDA inspection raised concerns about sterility assurance. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as High because it involves a risk-of-harm product (neonatal injectable preparation for vulnerable patients) where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bags containing amino acids (Trophamine 2%) and dextrose (10%) with added calcium and heparin, packaged in 250 mL bags for intravenous administration to neonates.
The recall was issued after an FDA inspection questioned whether these products, which are required to be sterile, actually meet the necessary sterility standards for their intended use.
The affected lot numbers are 37-897800 (expiration 05/12/2023) and 37-897895 (expiration 05/13/2023), encompassing 139 bags total. These products were distributed nationwide in the USA.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0416-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Hazard
- Affected units
- 139
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 # 37-897800
- Exp 05/12/2023
- 37-897895
- Exp 05/13/2023
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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