Central Admixture Pharmacy Recalls Compounded IV Infusion Bags for Sterility Failure
Central Admixture Pharmacy Services is recalling specific compounded IV infusion bags due to out-of-specification sterility test results indicating microbial contamination.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 3 bags of Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4%, Dextrose 5%, with additives including heparin and calcium gluconate. The product is a sterile injectable compounded drug packaged in 250 ml IV infusion bags.
The recall was initiated because the product failed sterility tests, resulting in out-of-specification results for microbial contamination. The affected lot number is 37-74775, with a manufacture date of December 15, 2014, and an expiration date of December 24, 2014.
The recall is classified as FDA Class I. Consumers and healthcare providers should stop using the affected product immediately and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 5%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contain
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded IV Infusion
- Affected units
- 3
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 37-74775
- Made on 15 DEC 2014
- EXP 24 DEC 2014
- CAPS Rx: 37-74775-0-3-R
- Disp ID: 37-1124582
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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