Neonatal TPN Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalled 485 bags of Neonatal TPN Starter Bag nationwide due to FDA concerns about manufacturing sterility assurance. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall of high-risk injectable medication for neonates due to manufacturing process concerns regarding sterility assurance. No illnesses have been reported, making this a risk-of-harm product where injury has not yet occurred, consistent with the rubric criterion for Score 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 485 bags of Neonatal TPN Starter Bag distributed nationwide in the USA. The product is a prescription injectable medication containing Amino Acids 3%, Dextrose 10%, low calcium, and Heparin in 250 mL bags.
The recall was initiated after an FDA inspection raised questions about the manufacturing process's assurance of sterility for these products. Affected lot numbers are 37-893805, 37-894711, 37-895258, 37-896501, 37-898160, 37-900064, and 37-900620, with expiration dates ranging from April 28, 2023 to May 25, 2023.
No illnesses or injuries related to these products have been reported. Healthcare facilities and providers should immediately stop use of affected lot numbers and contact Central Admixture Pharmacy Services for replacement product.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0428-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 485
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 (14)
- Lot # 37-893805
- Exp 04/28/2023
- 37-894711
- Exp 04/30/2023
- 37-895258
- Exp 05/04/2023
- 37-896501
- Exp 05/07/2023
- 37-898160
- Exp 05/13/2023
- 37-900064
- Exp 05/21/2023
- 37-900620
- Exp 05/25/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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