Sagent Pharmaceuticals has issued a nationwide recall on a painkiller. Three lots of Ketorolac Tromethamine Injection, a nonsteroidial anti-inflammatory drug, were recalled because the medications were printed with the incorrect expiration date. The labeled date is longer than the known stability of the drug.
Ketorolac Tromethamine is used short-term in postoperative patients to treat moderately severe acute pain that requires analgesia in patients already using opioid painkillers.
The affected lots include 30mg/mL single-dose vials with the NDC numbers 25021-701-01 and 25021-701-02. Affected lot numbers include MP5021, MP5024, and MP5025 and were distributed to hospitals, wholesalers and distributors across the country from Sept. 17 through Oct. 1, 2014. The drugs were manufactured by Cadila Healthcare Limited and distributed by Sagent.
Recipients of the recalled injections have been asked to examine their inventory immediately and to quarantine, discontinue distribution of, and return the recalled lots of the drugs.
Patients and health care professionals should report any serious side effects related to this recall to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.