Central Admixture Pharmacy Services Recalls Neonate D5 Bridge IV Infusion Bags
Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion bag due to out-of-specification sterility test results.
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 per the rubric mandates a severity score of 5 (Critical).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling two bags of Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bags. The recall is due to out-of-specification results for the sterility test for microbial contamination.
The affected product is identified by lot number 37-74755, made on 15 DEC 2014, with an expiration date of 24 DEC 2014. The CAPS Rx number is 37-74755-0-2-R, and the Disp ID is 37-1124670. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact Central Admixture Pharmacy Services, Inc. for further instructions.
The recalled product
- Product
- Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS,
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Hazard
- 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 37-74755
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74755-0-2-R
- Disp ID: 37-1124670.
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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