Hospira Inc.: 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

Is my product affected?

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

• Brand KETOROLAC TROMETHAMINE

Check against the official notice below — it lists the full affected range.

What happened

Hospira Inc. is recalling Ketorolac Tromethamine injectable medication in 30 mg/mL single-dose vials distributed nationwide and internationally to Guam and Singapore due to crystallization in the product. The recall affects approximately 13.7 million vials under the Hospira brand name and approximately 1.5 million vials under the NovaPlus label, with multiple lot numbers and expiration dates ranging from January 2015 through October 2016.

The affected products are identified by NDC numbers 0409-3795-01 (Hospira) and 0409-3795-49 (NovaPlus), along with specific lot numbers listed in the recall notice. The record does not specify what action consumers or healthcare facilities should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Crystallization

Details from the source

Reason for recall: Crystallization Distribution: U.S. Nationwide and International: Guam and Singapore. Quantity: HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials Lot/code info: NDC 0409-3795-01, Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015; Lot number 26-151-DK, Exp. Date:1FEB2015; Lot number: 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, Exp. Date:1APR2015; Lot number: 29-556-DK, 29-557-DK, Exp. Date:1MAY2015; Lot number: 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, Exp. Date:1NOV2015; Lot number: 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, Exp. Date:1DEC2015; Lot number: 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, Exp. Date:1JAN2016; Lot number: 38-141-DK, 38-143-DK, Exp. Date:1FEB2016; Lot number: 39-014-DK, 39-104-DK, Exp. Date:1MAR2016; Lot number: 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, Exp. Date:1APR2016; Lot number: 41-078-DK, Exp. Date:1MAY2016; Lot number: 42-207-DK, 42-253-DK, Exp. Date:1JUN2016; Lot number: 45-358-DK, 45-359-DK, Exp. Date:1SEP2016; Lot number: 46-043-DK, 46-044-DK, 46-047-DK, Exp. Date:1OCT2016 AND NOVAPLUS LABEL NDC 0409-3795-49, Lot number: 27-101-DK, Exp. Date:1MAR2015; Lot number: 35-229-DK, Exp. Date:1NOV2015; Lot number: 36-217-DK, 36-218-DK, Exp. Date:1DEC2015 and Lot number: 40-534-DK, Exp. Date:1APR2016

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 0409-3796-492015-01-23
• Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.2014-10-06
• 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 0409-3795-492015-06-30
• 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 0409-3796-492015-06-30
• AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 c2015-03-10

All FDA (Drug enforcement) recalls