CAPS Recalls Neonatal TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling five bags of neonatal TPN due to out-of-specification sterility test results.
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 according to the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling five bags of Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%. The product is a sterile injectable compounded drug packaged in 250 ml IV infusion bags. The recall is limited to lot number 37-74768, which was made on December 15, 2014, and has an expiration date of December 24, 2014.
The recall was initiated because the product failed sterility tests for microbial contamination. The source text identifies the issue as "Non-Sterility: Out of specification results for the sterility test for microbial contamination."
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled bags and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, 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, Allentown, PA.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 5
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 37-74768
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74768-0-5-R
- Disp ID: 37-1124563
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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