Drug product
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).
D-1048-2017
Product summary
- Event
- Event 77533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,034,600 10 mL multiple dose use vials
- Official record key
drug-enforcement:D-1048-2017
Official wording
Reason: Lack of Sterility Assurance
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
Distribution pattern: U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Derived failure modes
-
Sterility assurance
Lack of Sterility