Neonatal TPN Starter Bag Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.
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 is theoretical sterility assurance without confirmed contamination or patient harm, meeting the criterion for Score 3: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 92 bags of Neonatal TPN Starter Bag, a prescription medication containing Amino Acids (Trophamine) 2.5%, Dextrose 10%, calcium, and heparin in 250 mL packages. The product was distributed nationwide in the United States.
The FDA issued a Class II recall after inspection determined the manufacturer could not assure the sterility of the product. These products are labeled and intended to be sterile.
The recall affects two lot numbers: Lot #37-894334 (expiration 04/29/2023) and Lot #37-898299 (expiration 05/14/2023). The manufacturer is Central Admixture Pharmacy Services, Inc., located in Allentown, Pennsylvania.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/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 71285-0418-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- lack-of-sterility
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 (4)
- Lot # 37-894334
- Exp 04/29/2023
- 37-898299
- Exp 05/14/2023
Distribution
Distributed nationwide across the United States.
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