February 01, 2018
Sun Pharmaceutical Industries Inc. is recalling doxorubicin hydrochloride liposome injection, 20 mg/10 ml (2 mg/mL), 10-mL single-use vials (NDC 47335-049-40) due to a lack of sterility assurance, according to the January 31, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall spans 393 vials from lot JKS0403A (Exp. 2/19). The vials were distributed across the United States.
Sun Pharmaceutical Industries initiated the recall January 16, 2018. Three days later, the FDA designated the recall Class II. The categorization suggests use of the injection could cause a temporary health problem, but serious harm is not likely.
Doxorubicin hydrochloride liposome injection is indicated in the treatment of patients with ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.
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