Recalls / Class III
Class IIID-0836-2016
Product
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, 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 52-045-EV, Exp 07/1/2016
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 103,600 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-15
- FDA classified
- 2016-05-04
- Posted by FDA
- 2016-05-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0836-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.