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

FDA recall notice · announced April 15, 2015 · Central Admixture Pharmacy Services

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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 polystyrene insert; CAPS, Allentown, PA.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: lot number 37-74714, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74714-0-12-R, Disp ID: 37-1124493
Quantity: 12 bags
Status: Terminated
Products in this recall event:
- 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 (D-462-2015)
- 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 package (D-440-2015)
- 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 o (D-468-2015)
- 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 (D-465-2015)
- 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, I (D-443-2015)
- 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, s (D-447-2015)
- 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 on (D-460-2015)
- 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 ba (D-455-2015)
- 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 pa (D-450-2015)
- 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 corrugate (D-469-2015)
- 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 o (D-466-2015)
- 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 b (D-467-2015)
- 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 corr (D-446-2015)
- 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, compou (D-457-2015)
- 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, s (D-461-2015)
- 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 (D-444-2015)
- 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 d (D-449-2015)
- 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 in (D-463-2015)
- 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. (D-437-2015)
- 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 (D-438-2015)
- 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 on (D-453-2015)
- 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, c (D-442-2015)
- 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 b (D-441-2015)
- 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 packa (D-439-2015)
- 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 corrug (D-445-2015)
- 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, (D-448-2015)
- 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 corrugat (D-459-2015)
- 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 (D-464-2015)
- 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 packag (D-454-2015)
- 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 infusi (D-452-2015)
- 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 corrug (D-458-2015)
- 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 con (D-456-2015)
- 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 (D-451-2015)
- 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 dr (D-470-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.