Home / Recalls / Hospira Inc. / D-501-2013

D-501-2013 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-501-2013 was initiated by Hospira Inc. on May 16, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. The recall status is terminated (terminated Nov 10, 2014). Affected quantity: 95,700 vials.

Recall Details

Product Type: Drugs
Report Date: Jun 12, 2013
Initiation Date: May 16, 2013
Termination Date: Nov 10, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 95,700 vials

Product Description

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Reason for Recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

17-099-EV Exp 05/14

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-501-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Hospira Inc.

D-0862-2017 Class I — Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use… (Apr 21, 2017)
D-0153-2017 Class II — Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL… (Nov 1, 2016)
D-1500-2016 Class II — DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be… (Aug 15, 2016)
D-0169-2017 Class III — 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5… (Jun 29, 2016)
D-1359-2016 Class II — Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake… (Jun 23, 2016)
D-1033-2016 Class II — Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only… (May 6, 2016)
Z-1833-2016 Class II — The Plum A+ is a dual-line volumetric infusion system designed to meet the… (Mar 25, 2016)
Z-1832-2016 Class II — The Plum 360 is a large volume infuser capable of delivering fluids for a… (Mar 25, 2016)
D-1137-2016 Class I — Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20… (Mar 23, 2016)
D-0854-2016 Class III — Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20… (Mar 23, 2016)