Neonatal Injectable TPN Bags Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services recalled 877 bags of neonatal TPN starter bags nationwide due to lack of sterility assurance following an FDA 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 Class II recall of a high-risk parenteral product with sterility assurance failure. As a risk-of-harm product with no currently reported illnesses, the rubric score is 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 877 bags of Neonatal TPN Starter Bag (Trophamine 3% / Dextrose 10% with Calcium and Heparin) distributed nationwide. The recall was initiated after an FDA inspection raised concerns about whether the manufacturer could assure the product's sterility.
The affected product is a 250 mL injectable formulation intended for neonatal patients. Specific lot numbers and expiration dates have been identified. Because this product is intended to be sterile, any compromise in sterility assurance represents a potential risk of infection, particularly for vulnerable neonatal patients.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0420-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral / Injectable
- Hazard
- lack-of-sterility
- 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 (18)
- Lot # 37-894314
- Exp 04/29/2023
- 37-894690
- 37-894699
- Exp 04/30/2023
- 37-895627
- Exp 05/05/2023
- 37-896494
- Exp 05/07/2023
- 37-897082
- Exp 05/11/2023
- 37-897955
- Exp 05/13/2023
- 37-899254
- Exp 05/19/2023
- 37-900057
- 37-900060
- Exp 05/21/2023
Distribution
Distributed nationwide across the United States.
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