Home / Recalls / Hospira Inc. / D-0169-2017

D-0169-2017 Class III Terminated

Recalled by Hospira Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
December 14, 2016
Initiation Date
June 29, 2016
Termination Date
November 20, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
287,200 2 mL ampules

Product Description

5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

Reason for Recall

Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.

Distribution Pattern

US and Puerto Rico

Code Information

Lot # 34-547-DK, 34-548-DK, Exp. 10/16, Lot # 39-372-DK, Exp. 03/17 Lot Number may be followed by numbers from 01 to 99

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-1500-2016 Class II — DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Dil (August 15, 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-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-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-0865-2016 Class I — 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 (March 18, 2016)