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.