KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
Reported: April 15, 2015 Initiated: January 23, 2015 #D-0482-2015
Product Description
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
Reason for Recall
Crystallization
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials
- Distribution
- U.S. Nationwide and International: Guam and Singapore.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49. Recalled by Hospira Inc.. Units affected: HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials.
Why was this product recalled? ▼
Crystallization
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 15, 2015. Severity: Moderate. Recall number: D-0482-2015.
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