Home / Recalls / Hospira Inc. / D-1216-2015

D-1216-2015 Class I Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-1216-2015 was initiated by Hospira Inc. on Apr 23, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. The recall status is terminated (terminated Jan 26, 2016). Affected quantity: 150,950 Vials.

Recall Details

Product Type: Drugs
Report Date: Jul 15, 2015
Initiation Date: Apr 23, 2015
Termination Date: Jan 26, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 150,950 Vials

Product Description

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

Reason for Recall

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Distribution Pattern

U.S. Nationwide including Guam.

Code Information

Lot #: 38-515-DK, Expiry: 1 FEB 2016.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1216-2015
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)