April 2019 FDA Recall Ketorolac Tromethamine by Sagent Pharmaceuticals Inc
D-1274-2019 - Lack of Sterility Assurance

This Class II drug recall was voluntarily initiated by Sagent Pharmaceuticals Inc on April 30, 2019 for the product Ketorolac Tromethamine. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1274-2019

Reason for Recall
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Initiated
04-30-2019
Reported
05-15-2019
Quantity
75,825 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82741
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2020
Product Description About Product Description
Full technical description of the product.
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02

Batch or Lot Expiration Information

Lot# : M813513, Exp. Feb 2020

Affected Packages Involved in this Recall

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