FDA Recalls 20 Neonatal TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling 20 neonatal TPN bags because sterility tests showed microbial contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric. Additionally, the hazard involves microbial contamination in a sterile injectable product, posing a critical risk of serious injury or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 20 bags of Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag. The product is a compounded, sterile injectable IV infusion bag containing Trophamine 3% Dextrose 10%, heparin, and calcium gluconate.
The recall was initiated because the product failed sterility tests for microbial contamination. The affected lot number is 37-74914, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the recalled product immediately. The source text does not provide specific instructions for disposal or return, but standard protocol for recalled sterile medical products is to contact the prescribing physician or the recalling firm for guidance.
The recalled product
- Product
- Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 20
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 (5)
- lot number 37-74914
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74914-0-20-R
- Disp ID: 37-1124768
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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 34 products in this recall →Related recalls
Same manufacturer · Central Admixture Pharmacy Services, Inc.
See all →- ModeratePediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
- SeverePediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
- SevereInjectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
- HighEphedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- HighFDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighNeonatal TPN Starter Bags Recalled for Unassured Sterility
FDA (Drugs) · 2023-05-31
- HighNeonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-31
- HighNeonatal TPN starter bags recalled for lack of sterility assurance
FDA (Drugs) · 2023-08-09
- HighNeonatal TPN IV Bags Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-09-06
- HighNeonatal Injectable Nutrition Bags Recalled for Lack of Sterility Validation
FDA (Drugs) · 2023-09-06