Drug product
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
D-926-2013
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 66050
- Status
- Terminated
- Classification
- Class II
- Quantity
- 345,800 vials
- Official record key
drug-enforcement:D-926-2013
Official wording
Reason: Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Code information: Lot 25048DK Exp. 01/15
Distribution pattern: Naitonwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility