Home / Recalls / Hospira a Pfizer Company / D-1048-2017

D-1048-2017 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
15,034,600 10 mL multiple dose use vials

Product Description

Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).

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: 74393EV Exp. 05/01/2018 Lot: 75157EV Exp. 06/01/2018 Lot: 75367EV, Exp. 06/01/2018 b.) 25 vial carton Lot: 75158EV; Exp. 06/01/2018

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-1049-2017 Class II — Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vi (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)