Neonatal TPN Starter Bags Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 84 bags of neonatal TPN starter bags due to lack of sterility assurance and missing validation data for decontamination cycles.
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 involving a critical pharmaceutical product—sterile IV solution for neonates. While no illnesses or injuries have been reported, the hazard is significant: lack of sterility assurance in intravenous products for vulnerable neonatal patients represents a serious risk of harm if contamination occurred during manufacturing or decontamination.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 84 bags of Neonatal TPN Starter Bag (Amino Acids 3%/Dextrose 10% with Calcium, 250 mL) due to a lack of assurance of sterility and missing validation data for decontamination cycles.
The affected product is Lot 36-251696 with expiration date 7/15/2023 (NDC 72196-0405-1). The product was distributed nationwide in the United States.
Neonates receiving TPN from affected bags may have been exposed to potential contamination. Healthcare providers and pharmacies should identify patients who may have received this product and consult with appropriate authorities regarding monitoring and management of affected patients.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0405-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Affected units
- 84
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 (2)
- Lot: 36-251696
- Exp. 7/15/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 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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