The U.K. drugmaker originally recalled the product at the consumer level in December after finding “small visible particulate matters of a gelatinous/oily nature that appear black” in some lots of the drug. Hikma didn’t disclose what the particulate matter was.
The drugmaker said March 4 it is now expanding the recall to medical facilities and retailers.
Ketorolac tromethamine is an anti-inflammatory drug used to manage pain.
Hikma said using the recalled drug could result in the particulate matter going into patients’ lungs and cause acute respiratory distress.
The drugmaker said it hasn’t received any reports of adverse events related to the recalled drug.
Read the full news release here.
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