Neonatal TPN Starter Bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 80 Neonatal TPN Starter Bags due to lack of sterile assurance. Decontamination cycle validation data was not available, creating a potential contamination risk.
What this means for you
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 sterile injectable product for neonates with lack of documented sterility assurance and inadequate validation of manufacturing processes. No reported illnesses or injuries are documented in the source, consistent with Score 3 for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 80 Neonatal TPN Starter Bags (250mL IV bags containing Amino Acids 6%/Dextrose 10% with calcium and heparin) distributed nationwide in the USA. The recall was initiated due to lack of assurance of sterility and lacking validation data for decontamination cycles, which are critical for ensuring the safety of this parenteral nutrition product administered to neonates.
Affected lots include 36-251210 (expiration 7/10/2023) and 36-254921 and 36-254927 (expiration 7/22/2023). Neonates who received or may receive these products should be monitored for signs of infection or other complications. Healthcare providers and patients should contact Central Admixture Pharmacy Services or the FDA for guidance on return and replacement of affected bags.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0423-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Affected units
- 80
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 (5)
- Lot: 36-251210
- Exp. 7/10/2023
- 36-254921
- 36-254927
- 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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