FDA Recalls Six Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling six bags of compounded neonatal TPN because sterility tests failed. 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 source text identifies the agency classification as Class I, which corresponds to a Critical severity score per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling six bags of Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg. The product is a compounded drug packaged as a 500 ml IV infusion bag in a corrugated box. The recall was initiated because the product failed sterility tests for microbial contamination.
The affected product is identified by lot number 37-74651, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014. The specific CAPS Rx is 37-74651-0-6-R and the Disp ID is 37-1124745. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product and contact the recalling firm for further instructions. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml, Additives: heparin PF 250 units, Calcium Gluconate 1250mg, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 6
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 37-74651
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74651-0-6-R
- Disp ID: 37-1124745
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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