December 2020 FDA Recall Ketorolac Tromethamine by Fresenius Kabi Usa, Llc
D-0245-2021 - Presence of Particulate Matter - found in reserve sample vials at the firm.

This Class I drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on December 23, 2020 for the product Ketorolac Tromethamine. The FDA reported the reason for recall as presence of particulate matter - found in reserve sample vials at the firm.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0245-2021

Reason for Recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
Initiated
12-23-2020
Reported
02-03-2021
Quantity
945,425 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87082
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi USA, LLC
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.
06-09-2023
Product Description About Product Description
Full technical description of the product.
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Batch or Lot Expiration Information

Lot# 6121083, Exp 2/2021

Affected Packages Involved in this Recall

63323-161-00 Ketorolac Tromethamine
63323-161-01 Ketorolac Tromethamine
63323-162-11 Ketorolac Tromethamine
63323-162-51 Ketorolac Tromethamine
63323-162-00 Ketorolac Tromethamine
63323-162-01 Ketorolac Tromethamine
63323-162-03 Ketorolac Tromethamine
63323-162-02 Ketorolac Tromethamine