Home / Recalls / Hospira Inc. / D-0153-2017

D-0153-2017 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-0153-2017 was initiated by Hospira Inc. on November 1, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Complaints of broken tips on the ampules. The recall status is terminated (terminated August 28, 2018). Affected quantity: 797,800 ampules.

Recall Details

Product Type
Drugs
Report Date
November 30, 2016
Initiation Date
November 1, 2016
Termination Date
August 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
797,800 ampules

Product Description

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 for Recall

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

Distribution Pattern

Nationwide

Code Information

Lot #5 9277EV, 60028EV, 6008EV, Exp 11/1/17

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-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-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)

FDA data resources