Home / Recalls / Hospira a Pfizer Company / D-1049-2017

D-1049-2017 Class II Terminated

Recalled by Hospira a Pfizer Company — Rocky Mount, NC

Recall Details

Product Type
Drugs
Report Date
August 9, 2017
Initiation Date
June 15, 2017
Termination Date
July 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,436,700 5mL single dose vials

Product Description

Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA

Reason for Recall

Lack of Sterility Assurance

Distribution Pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

Code Information

a.) one vial: Lot: 72226EV Exp. 12/01/2018 Lot: 72236EV Exp. 12/01/2018 Lot: 75382EV Exp. 03/01/2019 Lot: 75383EV Exp. 03/01/2019 b.) 25 vial carton: Lot: 7538EV; Exp 03/01/2019

Other recalls by Hospira a Pfizer Company

  • D-1047-2017 Class II — 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (June 15, 2017)
  • D-1048-2017 Class II — Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose (June 15, 2017)
  • D-1046-2017 Class II — Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 (June 15, 2017)