FDA Drug recall D-0153-2017
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093…
- FDA Drug
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093… by Hospira, citing lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0153-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-01 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
Reason
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Identifiers
| code_info | Lot #5 9277EV, 60028EV, 6008EV, Exp 11/1/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Hospira
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FDA Drug · Class I · 2017-05-31 · Hospira - Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to…
FDA Device · Class II · 2017-01-18 · Hospira - 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured…
FDA Drug · Class III · 2016-12-14 · Hospira - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-11-16 · Hospira - Symbiq One Channel Infuser
FDA Device · Class II · 2016-11-16 · Hospira
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0153-2017%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.