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.
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 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…
- 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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