May 16, 2019
Sagent Pharmaceuticals Inc. is recalling 75,825 vials of ketorolac tromethamine injection, 60 mg/2 mL (30 mg/mL), due to a lack of sterility assurance, according to the May 15, 2019, US Food and Drug Administration (FDA) Enforcement Report.
“Microbial growth [was] detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products,” the FDA stated.
The recall affects 2-mL vials of ketorolac tromethamine injection (NDC 25021-701-02) from lot M813513 (Exp. 2/20). The product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals between January 2019 and March 2019 throughout the United States and in Puerto Rico.
Sagent Pharmaceuticals voluntarily initiated the recall April 30, 2019. On May 9, 2019, the FDA designated the recall Class II. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
“Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis,” Sagent Pharmaceuticals stated in an April 30, 2019, announcement. “The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.”
Ketorolac tromethamine injection is a prescription nonsteroidal anti-inflammatory drug used to treat moderately severe acute pain.