Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to 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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling four bags of Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg. The product is a compounded sterile injectable IV infusion bag containing amino acids, dextrose, heparin, and calcium gluconate. The recall was initiated because the product failed sterility tests for microbial contamination.
The affected product is identified by lot number 37-74652, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014. The recall number is D-461-2015. 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 on how to proceed.
The recalled product
- Product
- Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250 ml, Additives: heparin PF 125 unit(s)/ml, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a…
- 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 37-74652
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74652-0-4-R
- Disp ID: 37-1124739
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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