Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to non-sterility test failures. The product was distributed nationwide.
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 classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling four bags of Sinai Hospital (MD) TPN Neonatal Day 1 Bag. The product is a compounded sterile injectable IV infusion bag containing Trophamine 10 g, Dextrose 25 g, and Calcium Gluconate 1500 mg. The specific lot number is 37-74693, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014.
The recall was initiated because the product failed sterility tests for microbial contamination. The FDA has classified this recall as Class I, which is the most serious classification for drug recalls. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product immediately. Consumers should contact their healthcare provider for further instructions regarding the replacement or disposal of the recalled bags.
The recalled product
- Product
- Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, 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…
- 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 number 37-74693
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74693-0-4-R
- Disp ID: 37-1124640
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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