FDA Recalls Neonatal Parenteral Nutrition Bags for Sterility Concerns
Central Admixture Pharmacy Services recalled 328 neonatal parenteral nutrition bags nationwide due to FDA concerns about product sterility 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: This is a risk-of-harm product (parenteral nutrition for vulnerable neonatal patients) with a serious potential hazard (lack of sterility assurance), but no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury are scored at 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Neonatal PN Starter Bags (Amino Acids Trophamine 3.5%/Dextrose 10% with low calcium and heparin, 250 mL bags) nationwide. The recall affects lot numbers 37-894695, 37-895693, 37-900065, and 37-900622, totaling 328 bags.
The FDA determined during an inspection that the company could not provide adequate assurance of product sterility. These parenteral nutrition formulations are intended for intravenous use in neonatal patients and must meet strict sterility standards to prevent serious infections.
Healthcare providers and pharmacies that received these products should stop using them immediately and contact Central Admixture Pharmacy Services or the FDA for instructions on proper handling and replacement products. Patients who have received infusions from affected batches should consult their healthcare provider.
The recalled product
- Product
- Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Hazard
- lack-of-sterility-assurance
- infection-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 (8)
- Lot # 37-894695
- Exp 04/30/2023
- 37-895693
- Exp 05/05/2023
- 37-900065
- Exp 05/21/2023
- 37-900622
- Exp 05/25/2023
Distribution
Distributed nationwide across the United States.
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