The lot is being voluntarily recalled due to a detected microbial growth during a routine manufacturing simulation—indicating a potential introduction of microorganisms into the therapy.
The US Food and Drug Administration (FDA) has announced a nationwide recall of Ketorolac Tromethamine Injection 60 mg/2 mL from Sagent Pharmaceuticals.
The product, manufactured by Zydus and distributed by Sagent, is being recalled to the user level due to a detected microbial growth during a routine manufacturing simulation—indicating a potential introduction of microorganisms into the therapy.
The nonsteroidal, anti-inflammatory injection drug is indicated for the short-term management of moderately severe acute pain which requires opioid analgesia. The 1 lot being recalled was distributed to hospitals, wholesalers, and nationwide distributors from January to March of this year. The product is packaged in 2 ml glass vials.
Sagent has currently not received any reports of adverse events associated with the sterility issue, and no distributed product batches have yet been identified as actually containing microorganisms. That said, adult patients administered the therapy intravenously are at risk of sepsis infection, and the possibility of a breach in sterility assurance cannot be eliminated among distributed products.
The company has instructed customers and care providers to immediately examine their inventories, and to quarantine, discontinue distribution of, and return the recalled lot. Those who have further provided the therapy have been requested to identify patients and notify them immediately.
More information regarding the recall be found here.