Neonatal TPN Starter Bag Recall Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags because sterility cannot be assured and decontamination cycle validation data is lacking. The affected lot (36-254911) 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 a neonatal intravenous product due to sterility assurance failure. This affects a high-risk population (neonates), but the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling a lot of Neonatal TPN Starter Bag containing Amino Acids (trophamine) 2% and Dextrose 10% with Calcium, 250 mL IV bags. This is a prescription-only intravenous product.
The recall was initiated because there is a lack of assurance of sterility and validation data for decontamination cycles is lacking.
The affected lot (36-254911, expiration 7/22/2023, 48 bags total) was distributed nationwide in the United States. Healthcare facilities that received this product should verify whether they have inventory from this lot and follow appropriate handling procedures for the recalled product. Contact the manufacturer for further guidance.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 48
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: 36-254911
- Exp. 7/22/2023.
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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