Neonatal Parenteral Nutrition Bags Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalls 175 bags of neonatal TPN solution nationwide due to FDA inspection findings that questioned the sterility assurance of the product.
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 for sterile parenteral nutrition product intended for vulnerable neonatal patients. Lack of sterility assurance poses risk of serious infection. No illnesses or injuries reported in source. Per rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 175 bags of Neonatal TPN Starter Bag (Amino Acids [Trophamine] 4.5%/Dextrose 10% with HEPARIN, 250 mL per bag) distributed nationwide in the United States. The product is identified by National Drug Code (NDC) 71285-0432-1 and includes Lot #37-894962 (expiration 05/01/2023) and Lot #37-898285 (expiration 05/14/2023).
The recall was initiated following an FDA inspection that determined the company could not provide assurance of the sterility of this product intended for sterile parenteral use.
Lack of sterility assurance for products intended to be sterile poses a potential risk of infection in patients who receive them. Healthcare providers and patients with concerns about this product should contact Central Admixture Pharmacy Services at 6580 Snowdrift Road, Allentown, PA 18106.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 175
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 # 37-894962
- Exp 05/01/2023
- 37-898285
- Exp 05/14/2023
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.
See all 108 products in this recall →Related recalls
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