FDA Recalls Non-Sterile Compounded Neonatal IV Infusion Bags
Central Admixture Pharmacy Services is recalling 10 bags of compounded neonatal IV solution due to sterility test failures.
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 classified this recall as Class I, which is the highest severity level for drug recalls, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 10 bags of Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, with additives. The product is a sterile injectable, compounded drug packaged in 150 ml IV infusion bags. The recall is limited to lot number 37-74503, made on December 15, 2014, with an expiration date of December 24, 2014.
The recall was initiated because the product failed out-of-specification results for the sterility test, indicating microbial contamination. The FDA has classified this recall as Class I, which is the most serious classification for drug recalls.
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
- Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 10
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 37-74503
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74503-0-10-R
- Disp ID: 37-1124660
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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