CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling 4 bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 4 bags of Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10% compound. The product is a sterile injectable, prescription-only compounded drug packaged in 250 ml IV infusion bags. The recall is due to out-of-specification results for the sterility test, indicating microbial contamination.
The affected product includes lot numbers 37-74792 and 37-74635, which were made on December 15, 2014, and expire on December 24, 2014. The specific CAPS Rx numbers are 37-74792-0-2-R and 37-74635-0-2-R, with Disp IDs 37-1124677 and 37-1124679. The product was distributed nationwide.
Healthcare providers and patients should check their inventory for these specific lot numbers and discontinue use if found. The FDA has classified this as a Class I recall, which is the most serious type of recall where there is a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or the death.
The recalled product
- Product
- Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, 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
- 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 (5)
- lot numbers 37-74792 and 37-74635
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74792-0-2-R and CAPS Rx: 37-74635-0-2-R
- Disp ID: 37-1124677 and Disp ID: 37-1124679
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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