St Lukes East Lees Summit Protein Bag recalled over sterility concerns
- Recall date
- December 17, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Central Admixture Pharmacy Services, Inc. recalls St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, compound…
- Recall number
- D-454-2015
- FDA classification
- Class I
- Brand / firm
- Central Admixture Pharmacy Services, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, 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 insert; CAPS, Allentown, PA.
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