October 2014 FDA Recall Ketorolac Tromethamine by Sagent Pharmaceuticals Inc
D-0027-2015 - Incorrect or Missing Lot and/or Exp Date

This Class II drug recall was voluntarily initiated by Sagent Pharmaceuticals Inc on October 3, 2014 for the product Ketorolac Tromethamine. The FDA reported the reason for recall as incorrect or missing lot and/or exp date. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0027-2015

Reason for Recall
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Initiated
10-03-2014
Reported
10-22-2014
Quantity
69,050 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69485
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sagent Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-23-2016
Product Description About Product Description
Full technical description of the product.
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195

Batch or Lot Expiration Information

Lot# Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16

Affected Packages Involved in this Recall

25021-700-01 Ketorolac Tromethamine
25021-701-01 Ketorolac Tromethamine
25021-701-02 Ketorolac Tromethamine