Recalls / Class II
Class IID-315-2013
Product
QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02
- 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
- Lot 21-480-EV Exp.12/13
Why it was recalled
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 139,200 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-02-26
- FDA classified
- 2013-05-06
- Posted by FDA
- 2013-05-15
- Terminated
- 2014-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-315-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.