FDA Drug recall D-457-2015
Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq…
- FDA Drug
- Class I
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class I recall of Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq… 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-457-2015 |
| 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
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.
Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Identifiers
| code_info | lot number 37-74503, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74503-0-10-R, Disp ID: 37-1124660 |
|---|
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-457-2015%22
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