Hikma Extends Recall of Ketorolac Tromethamine Injection

Hikma Pharmaceuticals announces its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals) is voluntarily extending its previously-announced recall of certain lots 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.

The lots being recalled were manufactured between March 22, 2018, and February 21, 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.

Ketorolac Tromethamine Injection is a nonsteroidal anti-inflammatory drug (NSAID) that is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.

The complete list of recalled lots are availabe on the FDA website.

The product can be identified by name and NDC and lot codes, which are clearly stated on the product label, along with Hikma Pharmaceuticals USA/West-Ward Pharmaceutical Corp.’s name and address. Images of the vial and shelf pack labels are included below:

The product was distributed to Hikma’s direct customers nationwide. Hikma notified its direct customers as part of the initial recall, asking them to contact medical and retail level facilities to locate and remove the recalled product from distribution channels and return the recalled lots to Hikma. Hikma is now asking customers at the medical and retail level facilities to locate and remove the recalled product from their channels and return the recalled lots to Hikma.

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