Neonatal TPN IV Bags Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services recalled 96 neonatal TPN IV bags (Lot 36-256336) due to lack of sterility assurance and missing validation data for decontamination cycles. The product was distributed nationwide.
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: FDA Class II recall of an injectable product with a critical safety requirement (sterility). Although no illnesses or injuries have been reported, the risk-of-harm to neonatal patients is significant, as the contamination risk posed by unvalidated sterility assurance in injectable products presents a serious concern for this vulnerable population.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 96 neonatal TPN (total parenteral nutrition) Starter Bags containing Amino Acids 3%/Dextrose 5% with Calcium (250mL IV bags, NDC 72196-0413-1, Lot 36-256336, expiration 7/29/2023) due to a lack of assurance of sterility.
The recall is due to missing validation data for decontamination cycles. Sterility is essential for injectable products, and the absence of validated decontamination procedures creates a potential contamination risk for patients who receive these bags.
The affected lot was distributed nationwide. Healthcare providers and facilities should determine whether they received this product and handle it appropriately.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 96
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: 36-256336
- Exp. 7/29/2023.
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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