Neonatal TPN Starter Bags Recalled for Sterility Assurance Issue
Central Admixture Pharmacy Services recalls 138 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned the products' sterility assurance. Affected lots expire between 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: This is a Class II FDA recall with no reported illnesses or injuries in the source. The hazard—lack of sterility assurance on a high-risk parenteral nutrition product for neonates—represents a theoretical risk of contamination. Per the rubric, theoretical hazards without reported injury score at most 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 138 bags of Neonatal TPN Starter Bag (Amino Acids [Trophamine] 3.5%/Dextrose 10% with Calcium), packaged in 250 mL per bag. This prescription-only product is distributed nationwide.
The recall was initiated after an FDA inspection called into question the sterility assurance of the products. The affected lots are: Lot # 37-894709 (expiration 04/30/2023), Lot # 37-896128 (expiration 05/06/2023), and Lot # 37-897894 (expiration 05/13/2023).
Patients and healthcare providers who have this product should contact Central Admixture Pharmacy Services, Inc. for guidance on the product status and next steps.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0407-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Hazard
- Affected units
- 138
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 (6)
- Lot # 37-894709
- Exp 04/30/2023
- 37-896128
- Exp 05/06/2023
- 37-897894
- 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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