FDA Recalls Neonatal TPN Bags for Inadequate Sterility Validation
Central Admixture Pharmacy Services is recalling 192 bags of Neonatal TPN Starter Bag distributed nationwide due to lack of sterilization validation. The company cannot assure the product's sterility.
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 pharmaceutical recall of a sterile IV product for vulnerable neonatal patients without reported illnesses or confirmed contamination. The hazard is theoretical—insufficient validation of sterilization processes. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bag (250 mL intravenous bags containing Amino Acids 4% and Dextrose 10%) distributed nationwide. A total of 192 bags are affected by this recall.
The recall is due to lack of assurance of sterility. The company's validation data for decontamination cycles is insufficient, meaning there is inadequate documentation that the sterilization process was effective.
Affected lots include 36-251201 (expiration 7/10/2023), 36-254907 (expiration 7/22/2023), and 36-256030 (expiration 7/28/2023). Healthcare providers and patients should contact their healthcare provider or the manufacturer for further guidance on affected product units.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0408-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Nutrition
- Affected units
- 192
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 (6)
- Lot: 36-251201
- Exp. 7/10/2023
- 36-254907
- Exp. 7/22/2023
- 36-256030
- Exp. 7/28/2023.
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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