- Company Announcement Date:
- March 04, 2020
- FDA Publish Date:
- March 05, 2020
- Product Type:
- Reason for Announcement:
Potential Presence of Small Particulates
- Company Name:
- Hikma Pharmaceuticals USA Inc.
- Brand Name:
- Product Description:
Ketorolac Tromethamine Injection, USP 30mg/mL, 1 mL Vial
Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels. The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots.
On December 23, 2019, Hikma voluntarily initiated a recall of this product to the direct customer level. In coordination with the U.S. Food and Drug Administration (FDA), Hikma is extending the recall to the medical facility and retail levels.
Administration of the affected product could potentially result in the deposition of particulates in the lungs of patients, which could result in multiple pulmonary microemboli with subsequent acute respiratory distress for patients receiving the drug intravenously.
Although Hikma has not received any reports of adverse events related to this issue, it is nonetheless extending its recall of these products out of an abundance of caution and to promote patient safety, which is Hikma’s highest priority. (more…)