Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN solution due to failed sterility tests indicating 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 per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling four bags of Bridgeport Hospital (CT) TPN Neonatal Standard Solution. The product is a compounded, sterile injectable drug containing Trophamine 6% Dextrose 10%, heparin, and calcium gluconate, packaged in 150 ml IV infusion bags. The specific lot number is 37-74654, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014.
The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results. This indicates that the solution may not be sterile as required for intravenous administration.
The affected product was distributed nationwide. Healthcare providers and patients who have this specific lot of TPN solution should stop using it immediately and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Solution
- Affected units
- 4
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 (4)
- lot number 37-74654 Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74654-0-4-R
- Disp ID: 37-1124511
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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