Recalls / Class II
Class IID-1048-2017
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).
- Brand name
- Quelicin
- Generic name
- Succinylcholine Chloride
- Active ingredient
- Succinylcholine Chloride
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-6629, 0409-6970
- FDA application
- NDA008845
- Affected lot / code info
- 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
Why it was recalled
Lack of Sterility Assurance
Recalling firm
- Firm
- Hospira a Pfizer Company
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 4285 N Wesleyan Blvd, N/A, Rocky Mount, North Carolina 27804-8612
Distribution
- Quantity
- 15,034,600 10 mL multiple dose use vials
- Distribution pattern
- U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Timeline
- Recall initiated
- 2017-06-15
- FDA classified
- 2017-08-01
- Posted by FDA
- 2017-08-09
- Terminated
- 2020-07-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1048-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.