Drug 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
D-1242-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 71681
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Official record key
drug-enforcement:D-1242-2015
Official wording
Reason: Crystallization; identified as calcium salt of Ketorolac
Code information: 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
Distribution pattern: Nationwide, Puerto Rico, Guam, Canada and Singapore
Derived failure modes
-
Unknown
Crystallization; identified as calcium salt of Ketorolac