Recall of Compounded TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling five bags of compounded Total Parenteral Nutrition (TPN) because they failed sterility tests for 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 corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling five bags of Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g. The product is a compounded, sterile injectable IV infusion bag. The recall was initiated because the product failed sterility tests for microbial contamination, resulting in out-of-specification results.
The affected product is identified by lot number 37-74712, with a manufacture date of 15 DEC 2014 and an expiration date of 24 DEC 2014. The CAPS Rx number is 37-74712-0-1-R and the Disp ID is 37-1124468. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product immediately and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 5
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 37-74712
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74712-0-1-R
- Disp ID: 37-1124468
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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