CAPS Recalls Compounded TPN Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling four bags of compounded TPN infusion bags because they failed sterility tests for 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 is defined as a situation where use of or exposure to the product may cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling four bags of compounded Total Parenteral Nutrition (TPN) infusion bags. The product, identified as Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, is a sterile injectable compounded drug packaged in 250 ml IV infusion bags. The specific lot number is 37-74662, 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 product may not be sterile as required for intravenous administration.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product immediately and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 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
- 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 37-74662 Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74662-0-4-R
- Disp ID: 37-1124593
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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