Neonatal TPN Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 420 bags of neonatal TPN containing amino acids and dextrose due to lack of assurance of sterility. Validation data for decontamination cycles was not available.
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 initiated due to lack of sterility assurance in a neonatal intravenous product. No reported illnesses or injuries were mentioned in the source; the product poses a potential risk of harm to vulnerable neonatal patients, meeting the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 420 bags of Neonatal TPN Starter Bag containing Amino Acids (Trophamine) 3% and Dextrose 10% with low calcium and heparin. Each bag contains 250 mL of solution intended as an intravenous nutrition source for neonatal patients.
The recall was initiated due to lack of assurance of sterility. Validation data for the decontamination cycles used in manufacturing is lacking, which means the manufacturer cannot adequately confirm that the sterilization process was effective.
Affected lots are 36-251195 (expiration 7/10/2023), 36-252139 (7/16/2023), 36-252363 (7/17/2023), and 36-254922 (7/22/2023). The product was distributed nationwide throughout the United States.
Healthcare providers and patients with affected bags should contact Central Admixture Pharmacy Services, Inc. for guidance on handling and replacement of affected inventory.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 420
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 (8)
- Lot: 36-251195
- Exp. 7/10/2023
- 36-252139
- Exp. 7/16/2023
- 36-252363
- Exp. 7/17/2023
- 36-254922
- 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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