FDA Recalls 20 Neonatal TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling 20 neonatal TPN bags because sterility tests showed microbial contamination.
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 agency classification is FDA Class I, which mandates a severity score of 5 per the rubric. Additionally, the hazard involves microbial contamination in a sterile injectable product, posing a critical risk of serious injury or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 20 bags of Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag. The product is a compounded, sterile injectable IV infusion bag containing Trophamine 3% Dextrose 10%, heparin, and calcium gluconate.
The recall was initiated because the product failed sterility tests for microbial contamination. The affected lot number is 37-74914, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the recalled product immediately. The source text does not provide specific instructions for disposal or return, but standard protocol for recalled sterile medical products is to contact the prescribing physician or the recalling firm for guidance.
The recalled product
- Product
- Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contain
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 20
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 37-74914
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74914-0-20-R
- Disp ID: 37-1124768
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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