FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of neonatal TPN bags 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 two bags of Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm, Dextrose 10%, compound vol: 250 ml. The product is a sterile injectable, compounded drug packaged in an IV infusion bag. The recall is being conducted because the product failed sterility tests for microbial contamination.
The affected product is identified by lot number 37-74696, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014. The CAPS Rx number is 37-74696-0-2-R and the Disp ID is 37-1124636. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , 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
- 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 37-74696
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74696-0-2-R
- Disp ID: 37-1124636
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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