Drug recall D-1242-2015
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; identified as calcium salt of Ketorolac
Lots and codes
31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Distribution
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 30, 2015
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.