FDA (Drugs) recall action 70148

Central Admixture Pharmacy Services, Inc. recalled 34 products on 2015-04-15

The FDA (Drugs) publishes a recall like this one as 34 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 34 pages.

Products: 34
Announced: 2015-04-15
Critical: 34
Units: 187

Why these products were recalled

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–34 of 34

CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls Compounded TPN Infusion Bags
Central Admixture Pharmacy Services is recalling 4 bags of compounded TPN infusion bags due to non-sterility test failures.
Product
Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, 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,
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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Trophamine IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling Trophamine IV infusion bags because they failed sterility tests for microbial contamination.
Product
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,
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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling 4 bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
Product
Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, 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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CriticalFDA (Drugs)··2015-04-15
FDA Recalls Two Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of a compounded neonatal TPN product because sterility testing failed. The product was distributed nationwide.
Product
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contai
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN due to non-sterility test failures. The product was distributed nationwide.
Product
Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, 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; C
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CriticalFDA (Drugs)··2015-04-15
FDA Recalls Non-Sterile Neonatal TPN Bags Due to Microbial Contamination
Central Admixture Pharmacy Services is recalling 10 bags of neonatal TPN due to failed sterility tests indicating microbial contamination.
Product
Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls Non-Sterile Neonatal TPN Bags
Central Admixture Pharmacy Services is recalling four bags of neonatal TPN solution due to failed sterility tests indicating microbial contamination.
Product
Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is
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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Neonate Starter IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of Neonate Starter IV infusion bags because they failed sterility tests for microbial contamination.
Product
The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, 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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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Trophamine UAC Solution Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling Trophamine UAC Solution because it failed sterility tests for microbial contamination.
Product
Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g, compound vol: 100 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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