Home / Recalls / Hospira Inc. / D-1500-2016

D-1500-2016 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
September 21, 2016
Initiation Date
August 15, 2016
Termination Date
August 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24000 vials

Product Description

DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20

Reason for Recall

Discoloration: Firm received complaints of product discoloration and particulates.

Distribution Pattern

Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.

Code Information

Lot #: 52175DD, Exp 01 Oct 2016

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 Single- (April 21, 2017)
  • D-0153-2017 Class II — Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, (November 1, 2016)
  • D-0169-2017 Class III — 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 co (June 29, 2016)
  • D-1359-2016 Class II — Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake For (June 23, 2016)
  • D-1033-2016 Class II — Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira (May 6, 2016)
  • Z-1833-2016 Class II — The Plum A+ is a dual-line volumetric infusion system designed to meet the growi (March 25, 2016)
  • Z-1832-2016 Class II — The Plum 360 is a large volume infuser capable of delivering fluids for a variet (March 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 (March 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 (March 23, 2016)
  • D-0865-2016 Class I — 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 (March 18, 2016)