Central Admixture Pharmacy Services Recalls TPN Neonatal Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling 12 bags of Virginia Hospital Center TPN Neonatal Day 1 Bags due to out-of-specification sterility test results indicating 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 agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 12 bags of Virginia Hospital Center (VA) TPN Neonatal Day 1 Bags. The product is a compounded, sterile injectable drug containing Trophamine 5.5 gm, Dextrose 10%, and Calcium Gluconate, packaged in 250 ml IV infusion bags. The specific lot number is 37-74714, 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, resulting in out-of-specification results. This indicates a potential non-sterility issue that could pose a risk to patients receiving the intravenous infusion.
The affected product was distributed nationwide. Healthcare providers and patients who have received or possess this specific lot of TPN bags should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 12
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 37-74714
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74714-0-12-R
- Disp ID: 37-1124493
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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