Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
FDA recall notice · announced September 4, 2013 · Hospira
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Reason for recall
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Notes
Distribution: Naitonwide
Lot/code information: Lot 25048DK Exp. 01/15
Quantity: 345,800 vials
Status: Terminated
Products in this recall event:
- Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01 (D-926-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.