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D-1048-2017 Class II Terminated

Recalled by Hospira A Pfizer Company — Rocky Mount, NC

FDA drug recall D-1048-2017 was initiated by Hospira A Pfizer Company on Jun 15, 2017 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is terminated (terminated Jul 20, 2020). Affected quantity: 15,034,600 10 mL multiple dose use vials.

Recall details

Product Type: Drugs
Report Date: Aug 9, 2017
Initiation Date: Jun 15, 2017
Termination Date: Jul 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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1048-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.