Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalled 80 Neonatal TPN Starter Bags nationwide due to FDA concerns about sterility assurance after an inspection.
What this means for you
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 with no reported illnesses or injuries. The hazard—potential lack of sterility in a neonatal parenteral nutrition product—is theoretically serious but unconfirmed; this meets the High threshold as a risk-of-harm product without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. has recalled Neonatal TPN Starter Bags (Amino Acids 2% and Dextrose 10%, 250 mL bags). Eighty bags distributed nationwide are affected, with lot numbers 37-895214 (exp. 05/04/2023), 37-897950 (exp. 05/13/2023), and 37-899603 (exp. 05/20/2023), NDC 71285-0400-1.
Following an FDA inspection, the manufacturer's ability to assure the sterility of these products was called into question. Neonatal total parenteral nutrition products are administered directly into the bloodstream; contamination could expose vulnerable patients to serious infection.
Healthcare providers with affected bags should stop use immediately. Contact the manufacturer, Central Admixture Pharmacy Services, Inc., regarding return procedures. Any neonates who may have received affected products should be clinically monitored.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0400-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Hazard
- lack-of-sterility
- microbial-contamination
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 # 37-895214
- Exp 05/04/2023
- 37-897950
- Exp 05/13/2023
- 37-899603
- Exp 05/20/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27