Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 60 Neonatal TPN Starter Bags distributed nationwide due to sterility assurance concerns identified during 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: FDA Class II recall involving a neonatal injectable medication with unresolved sterility assurance concerns and no reported illnesses or injuries, fitting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bag containing Amino Acids (Trophamine) 6%, Dextrose 10%, low calcium, and HEPARIN in 250 mL bags. The recall affects 60 bags with the following lot numbers and expiration dates: 37-896506 (05/07/2023), 37-898306 (05/14/2023), and 37-900062 (05/21/2023). These bags were distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. During an FDA inspection, questions were raised concerning the sterility of the products, which are intended to be sterile. This is a Class II recall.
Healthcare providers and patients who have received or may receive these products should contact Central Admixture Pharmacy Services or their healthcare provider for guidance regarding the affected lots.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low 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 71285-0430-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance
- 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 # 37-896506
- Exp 05/07/2023
- 37-898306
- Exp 05/14/2023
- 37-900062
- Exp 05/21/2023
Distribution
Distributed nationwide across the United States.
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