Central Admixture Pharmacy Services Recalls Non-Sterile TPN Infusion Bags
Central Admixture Pharmacy Services is recalling five bags of Truman Medical Center Lakewood Starter TPN 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 is the highest severity level indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling five bags of Truman Medical Center Lakewood (MO) Starter TPN. The product is a compounded, sterile injectable IV infusion bag containing Trophamine 5.25g, Dextrose 10%, and Calcium Gluconate 4.8mEq, with a volume of 250 ml. The specific lot number is 37-74700, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014.
The recall was initiated because the product failed sterility tests, resulting in out-of-specification results for microbial contamination. This indicates that the product may not be sterile as required for intravenous use.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product immediately and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate 4.8mEq, compound vol: 250 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 37-74700
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74700-0-1-R
- Disp ID: 37-1124575
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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