Central Admixture Pharmacy Services Recalls NICU TPN Starter Due to Sterility Failure
Central Admixture Pharmacy Services is recalling a specific lot of NICU TPN Starter IV bags because sterility tests showed microbial contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 drug, posing a critical risk of serious injury or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling a specific lot of Olathe Medical Center (KS) NICU TPN Starter IV infusion bags. The recall was initiated because the product failed sterility tests, indicating out-of-specification results for microbial contamination.
The affected product is a compounded, sterile injectable drug intended for intravenous infusion. It is packaged in a corrugated box with a polystyrene insert. The specific lot number is 37-74547, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014. The distribution pattern is listed as nationwide.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 1
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 37-74547
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74547-0-1-R
- Disp ID: 37-1124708
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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