Medicine recalls
|
| |
| The United States: Hikma Pharmaceuticals USA Inc. extends voluntary nationwide recall of Ketorolac Tromethamine Injection, USP 30mg／ml, 1ml fill／2ml vials due to the potential presence of small particulates |
| |
The US Food and Drug Administration (FDA) announces that Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.) is voluntarily extending its previously-announced recall of certain lots of Ketorolac Tromethamine Injection, USP 30mg/ml, 1ml fill/2ml vials (lot number: 038366, 048365, 048367, 078301, 078303, 118358, 019413, 029353) 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 23 Dec 2019, Hikma voluntarily initiated a recall of this product to the direct customer level. In coordination with the 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.
The lots being recalled were manufactured between 22 Mar 2018 and 21 Feb 2019. Hikma investigated the cause of the problem and decided to suspend manufacturing of this product until an appropriate solution can be implemented to prevent recurrence.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-ketorolac-tromethamine-injection
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Mar 6, 2020
Issued at HKT 15:00
|
| |
