Recalls / Class II
Class IID-926-2013
Product
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-3793, 0409-3795, 0409-3796
- FDA application
- ANDA074802
- Affected lot / code info
- Lot 25048DK Exp. 01/15
Why it was recalled
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, Lake Forest, Illinois 60045
Distribution
- Quantity
- 345,800 vials
- Distribution pattern
- Naitonwide
Timeline
- Recall initiated
- 2013-08-12
- FDA classified
- 2013-08-28
- Posted by FDA
- 2013-09-04
- Terminated
- 2014-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-926-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.