Central Admixture Pharmacy Services Recalls TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling 5 bags of Total Parenteral Nutrition (TPN) compounded for Walter Reed National Military Medical Center because sterility tests failed.
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 (5).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 5 bags of Total Parenteral Nutrition (TPN) compounded for Walter Reed National Military Medical Center in Maryland. The specific product is a 200 ml sterile injectable IV infusion bag containing D10% without Ca, Trophamine 12g, and Dextrose 20g. The bags were packaged in corrugated boxes with polystyrene inserts.
The recall was initiated because the product failed out-of-specification results for the sterility test, indicating microbial contamination. The affected lot number is 37-74711, with a manufacturing date of December 15, 2014, and an expiration date of December 24, 2014. The recall is classified as Class I by the FDA.
The distribution pattern is listed as nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and discontinue use if found. The FDA has not reported specific illnesses or injuries in the source text, but the failure of sterility testing in an injectable product presents a significant risk of infection.
The recalled product
- Product
- Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, 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 insert; CAPS, Allentown, PA.
- 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 37-74711
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74711-0-5-R
- Disp ID: 37-1124477
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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