Neonatal TPN Starter Bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling 128 bags of Neonatal TPN Starter Bag after FDA inspection raised concerns about sterility assurance. The product is used for intravenous nutritional support in newborns.
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 hospitalizations. The hazard—lack of sterility assurance—is theoretical rather than confirmed, but the product is a high-risk neonatal IV medication where contamination could cause serious harm.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bag containing Amino Acids (Trophamine) 6%, Dextrose 10%, Calcium, and Heparin in 250 mL bags. The recall affects 128 units across three lot numbers (37-896152, 37-897923, and 37-899173) that were distributed nationwide in the United States.
The FDA initiated this recall after an inspection questioned the sterility assurance of the product. Neonatal TPN is a parenteral nutrition solution delivered intravenously to newborns. Lack of sterility assurance for intravenous medications poses a potential contamination risk that could affect patient safety.
Healthcare facilities and hospitals that received this product should immediately discontinue use and contact Central Admixture Pharmacy Services, Inc. for return and replacement instructions. Patients or parents with questions about whether their infant received this product should consult their healthcare provider.
This is an FDA Class II recall. For additional information, contact the manufacturer at their Allentown, Pennsylvania facility or visit the FDA's website.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/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 71285-0423-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- lack-of-sterility
- contamination-risk
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 # 37-896152
- Exp 05/06/2023
- 37-897923
- Exp 05/13/2023
- 37-899173
- Exp 05/19/2023
Distribution
Distributed nationwide across the United States.
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