Neonatal TPN Starter Bags Recalled Due to Sterility Validation Concerns
Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.
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: Lack of sterility assurance in neonatal intravenous nutrition products represents a risk-of-harm scenario. The FDA Class II classification combined with the absence of reported illnesses, injuries, or deaths aligns with the High severity category per FDA criteria.
Plain-English summary
Central Admixture Pharmacy Services is recalling 52 neonatal TPN (total parenteral nutrition) starter bags nationwide. The recalled product is a 250 mL intravenous bag containing amino acids (trophamine) 6%, dextrose 10%, low calcium, and heparin. The recall was initiated due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
The recall affects product with NDC 72196-0430-1 from two lot numbers: Lot 36-252367 (expiration 7/17/2023) and Lot 36-256528 (expiration 7/29/2023). The product was distributed nationwide in the United States.
Patients and healthcare providers who have received or are holding the affected neonatal TPN starter bags should immediately cease use and contact Central Admixture Pharmacy Services or consult their healthcare provider for replacement product. The FDA has not reported any illnesses or injuries associated with this recall as of this notice.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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: 72196-0430-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Parenteral Nutrition
- Hazard
- sterility-assurance-failure
- sterilization-validation-failure
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: 36-252367
- Exp. 7/17/2023
- 36-256528
- Exp. 7/29/2023
Distribution
Distributed nationwide across the United States.
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