Ketorolac Tromethamine Injection, Solution
FDA Recall NDC 0409-3796
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Ketorolac Tromethamine (NDC 0409-3796). A significant event, classified as Class II, was initiated on Jun 30, 2015 by Hospira, Inc.. The reported reason for this action was: "Crystallization; identified as calcium salt of Ketorolac"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
June 2015 Class II Recall: Crystallization; identified as calcium salt of Ketorolac
Recall Number
Class II Ongoing
Crystallization; identified as calcium salt of Ketorolac
Jun 30, 2015
Jul 22, 2015
5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
Recall Profile & Regulatory Data
Event ID
71681
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, Guam, Canada and Singapore
Product Description
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0409-3793-19Product
0409-3793-01Product
0409-3793-25Product
0409-3795-19Product
0409-3795-01Product
0409-3795-25Product
0409-3796-19Product
0409-3796-01Product
0409-3796-25Product
0409-3796-49Product
June 2015 Class II Recall: Crystallization; identified as calcium salt of Ketorolac
Recall Number
Class II Ongoing
Crystallization; identified as calcium salt of Ketorolac
Jun 30, 2015
Jul 22, 2015
12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
Recall Profile & Regulatory Data
Event ID
71681
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, Guam, Canada and Singapore
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
Batch or Lot Expiration Information
Lot# 31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016
Affected Packages Involved in this Recall
0409-3793-19Product
0409-3793-01Product
0409-3793-25Product
0409-3795-19Product
0409-3795-01Product
0409-3795-25Product
0409-3796-19Product
0409-3796-01Product
0409-3796-25Product
0409-3795-49Product
Class II Terminated
Crystallization
Jan 23, 2015
Apr 15, 2015
HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials
Recall Profile & Regulatory Data
Event ID
70515
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide and International: Guam and Singapore.
Termination Date
Feb 04, 2016
Product Description
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
Batch or Lot Expiration Information
Lot# NDC 0409-3796-01, Lot number: 26-098-DK, Exp. Date:1FEB2015; Lot number: 29-239-DK, 29-240-DK, Exp. Date:1MAY2015; Lot number: 34-540-DK, Exp. Date:1OCT2015; Lot number: 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, Exp. Date:1JAN2016; Lot number: 41-282-DK, 41-284-DK, Exp. Date:1MAY2016; Lot number: 44-076-DK, Exp. Date:1AUG2016; Lot number: 45-240-DK, Exp. Date:1SEP2016 and Lot number: 46-306-DK, Exp. Date:1OCT2016 AND NOVAPLUS label NDC 0409-3796-49, Lot number: 26-097-DK, Exp. Date:1FEB2015.
Affected Packages Involved in this Recall
0409-3793-19Product
0409-3793-01Product
0409-3793-25Product
0409-3795-19Product
0409-3795-01Product
0409-3795-25Product
0409-3796-19Product
0409-3796-01Product
0409-3796-25Product
0409-3796-49Product
Class II Terminated
Crystallization
Jan 23, 2015
Apr 15, 2015
HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials
Recall Profile & Regulatory Data
Event ID
70515
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide and International: Guam and Singapore.
Termination Date
Feb 04, 2016
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0409-3793-19Product
0409-3793-01Product
0409-3793-25Product
0409-3795-19Product
0409-3795-01Product
0409-3795-25Product
0409-3796-19Product
0409-3796-01Product
0409-3796-25Product
0409-3795-49Product
Class II Terminated
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Oct 06, 2014
Feb 25, 2015
100 vials
Recall Profile & Regulatory Data
Event ID
69573
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
Termination Date
Dec 15, 2016
Product Description
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.
Batch or Lot Expiration Information
Lot# One shipment of
Lot# : 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
Affected Packages Involved in this Recall
0409-3793-19Product
0409-3793-01Product
0409-3793-25Product
0409-3795-19Product
0409-3795-01Product
0409-3795-25Product
0409-3796-19Product
0409-3796-01Product
0409-3796-25Product
Class II Terminated
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
Aug 12, 2013
Sep 04, 2013
345,800 vials
Recall Profile & Regulatory Data
Event ID
66050
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Naitonwide
Termination Date
Oct 28, 2014
Product Description
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Batch or Lot Expiration Information
Lot# Lot 25048DK Exp. 01/15
Affected Packages Involved in this Recall
0409-3793-19Product
0409-3793-01Product
0409-3793-25Product
0409-3795-19Product
0409-3795-01Product
0409-3795-25Product
0409-3796-19Product
0409-3796-01Product
0409-3796-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
