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.
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 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
- Hazard
- sterility-failure
- contamination-risk
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.
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