WASHINGTON, D.C. — Hikma Pharmaceuticals, once known as West-Ward Pharmaceuticals Corporation, or Hikma, announced that it must extend its recall campaign for its Ketorolac Tromethamine Injection USP 30mg/mL, 1mL fill/2mL vials at both the retail and medical facility levels. According to the press release published by the U.S. Food and Drug Administration (FDA), the injectable medication contains a black, gelatinous or oily particulate that, although small, are visible in many of the recalled lots of the medication. Hikma started the first phase of its voluntary recall on December 23, 2019. A patient who receives a tainted dose of the medication could suffer acute respiratory distress. Hikma said that it has not received any reports of adverse events and issued the recall to ensure the safety of patients who need the drug.
Hikma announced that the company suspended producing the drug to prevent the distribution of more tainted lots to medical facilities and retail pharmacies nationwide. The company has not devised a way to manufacture the drug without the contaminates. Moreover, the company could not determine why the particulates appear in the medication. Lots of the Ketorolac Tromethamine recalled by Hikma were produced by the company between March 22, 2018, and February 21, 2019.
Hikma’s Ketorolac Tromethamine Injection is an NSAID or nonsteroidal anti-inflammatory drug which is used on a short-term basis for pain management. The typical course of treatment with the recalled drug lasts only five days. Ketorolac Tromethamine Injections are an alternative to opioid painkillers. Hikma asked its distributors, and now physicians to return the recalled lots of the drug as soon as possible and to stop using the product immediately.
Any person who possesses the recalled drug or who is unsure if they have a recalled medication should contact their physician immediately for medical advice. Additionally, any adverse reactions to this and any medication should be reported to FDA’s MedWatch program.
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