Why it was recalled
Lack of Sterility Assurance
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).
Lot numbers, UPCs & expiration codes
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
Where it was sold
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1048-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 15, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 15,034,600 10 mL multiple dose use vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira a Pfizer Company
Original FDA data
Every field from FDA enforcement report D-1048-2017, exactly as published.
Show all FDA fields
- City
- Rocky Mount
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 77533
- Address
- 4285 N Wesleyan Blvd
- 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
- Postal code
- 27804-8612
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1048-2017
- Classification
- Class II
- Recalling firm
- Hospira a Pfizer Company
- Product quantity
- 15,034,600 10 mL multiple dose use vials
- Termination date
- Jul 20, 2020
- Reason for recall
- Lack of Sterility Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
- Recall initiation date
- Jun 15, 2017
- Initial firm notification
- Press Release
- Center classification date
- Aug 1, 2017