FDA Drug recall D-450-2015
Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, ste…
- FDA Drug
- Class I
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class I recall of Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, ste… by Central Admixture Pharmacy Services, citing non-Sterility: Out of specification results for the sterility test for microbial contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-450-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-12-17 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
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; CAPS, Allentown, PA.
Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Identifiers
| code_info | lot number 37-74693, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74693-0-4-R, Disp ID: 37-1124640 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-450-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.