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
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 Neonate D5 Bridge IV Infusion Bags
Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion bag due to out-of-specification sterility test results.
Product
Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 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
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
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.
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…
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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…
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls TPN Neonate Starter Bags for Sterility Issues
Central Admixture Pharmacy Services is recalling 10 bags of TPN Neonate Starter Bags due to out-of-specification sterility test results indicating microbial contamination.
Product
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 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
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
Central Admixture Pharmacy Services Recalls Compounded TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling three bags of compounded TPN due to out-of-specification sterility test results indicating microbial contamination.
Product
Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a…
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CriticalFDA (Drugs)··2015-04-15
FDA Recalls Non-Sterile Compounded Neonatal IV Infusion Bags
Central Admixture Pharmacy Services is recalling 10 bags of compounded neonatal IV solution due to sterility test failures.
Product
Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/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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