FDA Drug Moderate Class II Ongoing

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: July 22, 2015 Initiated: June 30, 2015 #D-1241-2015

Product Description

Reason for Recall

Crystallization; identified as calcium salt of Ketorolac

Details

Recalling Firm: Hospira Inc.
Units Affected: 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
Distribution: Nationwide, Puerto Rico, Guam, Canada 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: 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label).

Why was this product recalled? ▼

Crystallization; identified as calcium salt of Ketorolac

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on July 22, 2015. Severity: Moderate. Recall number: D-1241-2015.