Multi-event June 2015 FDA Recall Ketorolac Tromethamine by Hospira Inc.
This Multi-event Class II drug recall was voluntarily initiated by Hospira Inc. on June 30, 2015 for the product Ketorolac Tromethamine. The FDA reported the reason for recall as crystallization; identified as calcium salt of ketorolac. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-1242-2015
Crystallization; identified as calcium salt of Ketorolac
06-30-2015
07-22-2015
5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Puerto Rico, Guam, Canada and Singapore
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
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
Recall Number: D-1241-2015
Crystallization; identified as calcium salt of Ketorolac
06-30-2015
07-22-2015
12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Puerto Rico, Guam, Canada and Singapore
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
