Neonatal TPN solution recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 296 bags of neonatal TPN starter solution due to lacking validation data for decontamination cycles, raising concerns about sterility assurance.
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 a compounded sterile injectable product. Although no illnesses or injuries have been reported, the lack of validated decontamination procedures creates a risk of contamination in a critical product intended for neonatal patients. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 296 bags of Neonatal TPN Starter Bag containing Amino Acids (Trophamine) 2.5%, Dextrose 10%, Calcium, and Heparin (250 mL, NDC 72196-0418-1) distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. The company lacked validation data for its decontamination cycles, which are essential controls for compounded sterile pharmaceutical preparations.
The affected lot numbers are 36-251202 with expiration 7/10/2023 and 36-252135 with expiration 7/16/2023. These products are prescribed intravenously and intended for neonatal nutrition support. Patients and healthcare providers who have received these products should consult their healthcare provider regarding appropriate follow-up.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 296
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: 36-251202
- Exp. 7/10/2023
- 36-252135
- Exp. 7/16/2023.
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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