Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 224 neonatal TPN starter bags (250mL IV bags) distributed nationwide due to lack of sterility assurance and insufficient 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: FDA Class II recall with no reported illnesses or injuries, but the hazard involves lack of sterility assurance in an intravenous neonatal product, which is a high-risk situation. Score 3 applies under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 224 units of Neonatal TPN Starter Bag (Amino Acids 3%/Dextrose 5% with Calcium and Heparin, 250mL intravenous bags, NDC 72196-0419-1) distributed nationwide. The recall affects two lots: Lot 36-251207 (expires 7/10/2023) and Lot 36-256337 (expires 7/29/2023).
The product is being recalled because validation data for decontamination cycles is lacking, resulting in a lack of assurance of sterility. Since these are intravenous bags administered to neonatal patients, sterility is critical to ensure safety.
Healthcare providers who have this product should contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043 for further information and instructions.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 224
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: 36-251207
- Exp. 7/10/2023
- 36-256337
- 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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