Recalls / Class II
Class IID-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
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-3793, 0409-3795, 0409-3796
- FDA application
- ANDA074802
- Affected lot / code info
- 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
Why it was recalled
Crystallization; identified as calcium salt of Ketorolac
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Distribution pattern
- Nationwide, Puerto Rico, Guam, Canada and Singapore
Timeline
- Recall initiated
- 2015-06-30
- FDA classified
- 2015-07-15
- Posted by FDA
- 2015-07-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1242-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.