Hikma Pharmaceuticals USA Inc., the U.S.-based business of Hikma Pharmaceuticals PLC, extended its previously announced recall of certain lots of pain and inflammation medication Ketorolac Tromethamine in the form of injection for the potential presence of small visible particulate matters.
The particulates are of gelatinous/oily nature that appears black in some of the recalled lots of the injection.
Hikma had previously initiated a recall of this product to the direct customer level on December 23, 2019. It is now extending the recall to the medical facility and retail levels.
The generic and in-licensed pharma company is now recalling eight lots of Ketorolac Tromethamine Injection USP of 30mg/mL, 1mL fill/2mL vials with expiration dates between March 2020 and January 2021.
The recalled products were manufactured between March 22, 2018, and February 21, 2019 and were distributed across the U.S. to Hikma’s direct customers.
The company noted that the 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.
Hikma is yet to receive any reports of adverse events directly related to the recalled lots.
Hikma asked customers remove the recalled product from their channels and return them to the company.
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.
Heartburn medication Ranitidine was subject to multiple recalls recently. Several drug companies in the U.S. have issued recalls for Ranitidine, sold under the trade name Zantac among others, on confirmation of NDMA contamination above levels set by the FDA.
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