A recall of 1 lot of Ketorolac Tromethamine Injection 60mg/2mL (30mg/mL) has been initiated by Sagent Pharmaceuticals following the discovery of microbial growth during a routine simulation of the manufacturing process.
Concerns over the possible introduction of microorganisms into the product led the Company to issue the recall to the user level. The product is supplied in 2mL glass tubular vials and has a lot number of M813513 with an expiration date of February 2020; it was distributed between January 2019 and March 2019. Currently, none of the distributed batches have been identified as containing microorganisms; adverse events related to this recall have also not been reported at this time.
Ketorolac Tromethamine Injection, a nonsteroidal anti-inflammatory drug (NSAID), 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. It may be administered either intramuscularly or intravenously; the 60mg dose is indicated for intramuscular use only.
Healthcare workers who have questions about the recall can call (866) 625-1618 and choose Option 3 to contact Medical Affairs.
For more information visit sagentpharma.com.