FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of a compounded neonatal TPN product because sterility testing failed. The product was distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which corresponds to a Critical severity score per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling two bags of Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium. The product is a compounded drug, sterile injectable IV infusion bag containing Trophamine 5 gm, Dextrose 10%, and Calcium Gluconate. Each bag has a volume of 250 ml and is packaged in a corrugated box with a polystyrene insert.
The recall was initiated because the product failed sterility testing for microbial contamination. The specific lot number is 37-74695, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014. The distribution pattern for this recall is nationwide.
Healthcare facilities and patients who have received this specific product should contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contai
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 2
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 number 37-74695
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74695-0-2-R
- Disp ID: 37-1124634
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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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