Central Admixture Pharmacy Services Recalls TPN Neonatal Starter Bags
Central Admixture Pharmacy Services is recalling TPN Neonatal Starter IV infusion bags due to out-of-specification sterility test results.
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 TPN Neonatal Starter 0.4-0.599 Kg IV infusion bags. The product is a compounded drug containing amino acids, dextrose, heparin, and calcium gluconate, packaged in 150 ml sterile injectable bags. The recall is limited to lot number 37-74653, which was made on December 15, 2014, and has an expiration date of December 24, 2014.
The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results. This indicates a potential risk of non-sterility in the affected bags.
The affected product was distributed nationwide. Healthcare providers and patients who have used or possess this specific lot should contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — IV Infusion
- Affected units
- 1
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 37-74653
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74653-0-1-R
- Disp ID: 37-1124735
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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