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.

1–25 of 34

CriticalFDA (Drugs)··2015-04-15
FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
Product
Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a poly
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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Lankenau Hospital TPN Neonatal Starter Bags for Sterility Failure
Central Admixture Pharmacy Services is recalling six Lankenau Hospital TPN Neonatal Starter Bags due to out-of-specification sterility test results.
Product
Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined wit
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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 lined
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls Compounded IV Infusion Bags
Central Admixture Pharmacy Services is recalling 8 bags of compounded IV infusion bags due to out-of-specification sterility test results.
Product
Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, 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
Recall of Compounded TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling five bags of compounded Total Parenteral Nutrition (TPN) because they failed sterility tests for microbial contamination.
Product
Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, compound vol: 200 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
FDA Recalls Compounded Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling compounded neonatal IV infusion bags because they failed sterility tests for microbial contamination.
Product
Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a p
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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 sterility test failures. The product was distributed nationwide.
Product
Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250 ml, Additives: heparin PF 125 unit(s)/ml, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corr
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls TPN Neonatal Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling 12 bags of Virginia Hospital Center TPN Neonatal Day 1 Bags due to out-of-specification sterility test results indicating microbial contamination.
Product
Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 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
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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Compounded TPN Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling four bags of compounded TPN infusion bags because they failed sterility tests for microbial contamination.
Product
Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, 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,
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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, Allen
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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Neonatal TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling five bags of neonatal TPN due to out-of-specification sterility test results.
Product
Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, 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 20 Bags of TPN Neonatal Starter Bag for Sterility Failure
Central Admixture Pharmacy Services is recalling 20 bags of University of Alabama Birmingham TPN Neonatal Starter Bag due to out-of-specification sterility test results.
Product
University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, 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
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 corru
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CriticalFDA (Drugs)··2015-04-15
FDA Recalls Six Bags of Neonatal TPN Due to Sterility Failure
Central Admixture Pharmacy Services is recalling six bags of compounded neonatal TPN because sterility tests failed. The product was distributed nationwide.
Product
Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml, Additives: heparin PF 250 units, Calcium Gluconate 1250mg, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls Neonate TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling six bags of neonate TPN starter bags due to out-of-specification sterility test results indicating microbial contamination.
Product
Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each containe
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls TPN Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling 5 bags of Total Parenteral Nutrition (TPN) compounded for Walter Reed National Military Medical Center because sterility tests failed.
Product
Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200 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
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 inser
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CriticalFDA (Drugs)··2015-04-15
CAPS Recalls Neonatal IV Infusion Bags Due to Sterility Failure
Central Admixture Pharmacy Services is recalling two bags of a neonatal IV infusion compound because sterility testing failed.
Product
Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, 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 20 Neonatal TPN Bags Due to Sterility Test Failures
Central Admixture Pharmacy Services is recalling 20 neonatal TPN bags because sterility tests showed microbial contamination.
Product
Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each contain
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CriticalFDA (Drugs)··2015-04-15
Central Admixture Pharmacy Services Recalls TPN Neonatal Starter Bags
Central Admixture Pharmacy Services is recalling TPN Neonatal Starter IV infusion bags due to out-of-specification sterility test results.
Product
Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated
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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 TPN Infusion Bags
Central Admixture Pharmacy Services is recalling 3 bags of compounded TPN infusion bags due to non-sterility test failures.
Product
Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, 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 conta
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CriticalFDA (Drugs)··2015-04-15
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.
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
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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 neonatal TPN bags due to out-of-specification sterility test results.
Product
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , 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
Central Admixture Pharmacy Services Recalls NICU TPN Starter Due to Sterility Failure
Central Admixture Pharmacy Services is recalling a specific lot of NICU TPN Starter IV bags because sterility tests showed microbial contamination.
Product
Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a pol
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