Drug recall D-0483-2015
Product
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
Reason for recall
Crystallization
Lots and codes
NDC 0409-3796-01, Lot number: 26-098-DK, Exp. Date:1FEB2015; Lot number: 29-239-DK, 29-240-DK, Exp. Date:1MAY2015; Lot number: 34-540-DK, Exp. Date:1OCT2015; Lot number: 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, Exp. Date:1JAN2016; Lot number: 41-282-DK, 41-284-DK, Exp. Date:1MAY2016; Lot number: 44-076-DK, Exp. Date:1AUG2016; Lot number: 45-240-DK, Exp. Date:1SEP2016 and Lot number: 46-306-DK, Exp. Date:1OCT2016 AND NOVAPLUS label NDC 0409-3796-49, Lot number: 26-097-DK, Exp. Date:1FEB2015.
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials
- Distribution
- U.S. Nationwide and International: Guam and Singapore.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 23, 2015
- Terminated
- February 4, 2016
Related products
- Ketorolac Tromethamine – drug information
- NDC 0409-3795 Ketorolac Tromethamine · Ketorolac Tromethamine 30 mg/mL · Hospira, Inc.
- NDC 0409-3793 Ketorolac Tromethamine · Ketorolac Tromethamine 15 mg/mL · Hospira, Inc.
- NDC 0409-3796 Ketorolac Tromethamine · Ketorolac Tromethamine 60 mg/2mL · Hospira, Inc.