openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 34
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
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74529, EXP: 24 DEC 2014, Made on 15 DEC 2014, CAPS Rx: 37-74529-0-20-R, Disp ID: 37-1124540
Distribution pattern
Nationwide
drug · product 2 of 34
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, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74731, EXP 24 DEC 2014, Made on 15 DEC 2014, CAPS Rx: 37-74731-0-10-R, Disp ID: 37-1124452.
Distribution pattern
Nationwide
drug · product 3 of 34
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, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74756, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74756-0-8-R, Disp ID: 37-1124668.
Distribution pattern
Nationwide
drug · product 4 of 34
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, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74755, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74755-0-2-R, Disp ID: 37-1124670.
Distribution pattern
Nationwide
drug · product 5 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74765, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74765-0-1-R, Disp ID: 37-1124732
Distribution pattern
Nationwide
drug · product 9 of 34
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, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74661 Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74661-0-4-R, Disp ID: 37-1124589
Distribution pattern
Nationwide
drug · product 10 of 34
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, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74767, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74767-0-3-R, Disp ID: 37-1124457
Distribution pattern
Nationwide
drug · product 12 of 34
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 polystyrene insert; CAPS, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74693, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74693-0-4-R, Disp ID: 37-1124640
Distribution pattern
Nationwide
drug · product 15 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74711, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74711-0-5-R, Disp ID: 37-1124477
Distribution pattern
Nationwide
drug · product 16 of 34
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 insert; CAPS, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74680, Made on 15 DEC 2014, EXP 24 DEC 2014,CAPS Rx: 37-74680-0-6-R, Disp ID: 37-1124687
Distribution pattern
Nationwide
drug · product 18 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74520, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74520-0-6-R, Disp ID: 37-1124617
Distribution pattern
Nationwide
drug · product 19 of 34
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 insert; CAPS, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74700, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74700-0-1-R, Disp ID: 37-1124575
Distribution pattern
Nationwide
drug · product 20 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74699, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74699-0-5-R, Disp ID: 37-1124574
Distribution pattern
Nationwide
drug · product 21 of 34
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 with a polystyrene insert; CAPS, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74503, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74503-0-10-R, Disp ID: 37-1124660
Distribution pattern
Nationwide
drug · product 22 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot numbers 37-74792 and 37-74635, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74792-0-2-R and CAPS Rx: 37-74635-0-2-R, Disp ID: 37-1124677 and Disp ID: 37-1124679
Distribution pattern
Nationwide
drug · product 23 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74634, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74634-0-2-R, Disp ID: 37-1124681
Distribution pattern
Nationwide
drug · product 24 of 34
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 container is lined with a polystyrene insert; CAPS, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74775, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74775-0-3-R, Disp ID: 37-1124582
Distribution pattern
Nationwide
drug · product 31 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74768, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74768-0-5-R, Disp ID: 37-1124563
Distribution pattern
Nationwide
drug · product 32 of 34
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 container is lined with a polystyrene insert; CAPS, Allentown, PA.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74695, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74695-0-2-R, Disp ID: 37-1124634
Distribution pattern
Nationwide
drug · product 33 of 34
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Code information
lot number 37-74696, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74696-0-2-R, Disp ID: 37-1124636
Distribution pattern
Nationwide
drug · product 34 of 34
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.
