Central Admixture Pharmacy Services Recalls Neonate TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling six bags of neonate TPN starter 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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling six bags of Providence Hospital Southfield (MI) Neonate TPN Starter Bags. The product is a compounded drug containing Trophamine 3g, Dextrose 10%, heparin, and Calcium Gluconate, packaged as a 150 ml sterile injectable IV infusion bag.
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 infection if the product is administered to patients.
The affected product is identified by lot number 37-74680, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014. The recall is classified as FDA Class I. Healthcare providers and patients should stop using the affected product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each…
- 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 37-74680
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74680-0-6-R
- Disp ID: 37-1124687
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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