December 03, 2020
Nearly 17,000 single-dose vials of doxorubicin hydrochloride injection are being recalled by Fresenius Kabi USA after testing revealed trace amounts of octreotide, according to the December 2, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects doxorubicin hydrochloride injection, 10 mg/5 mL (2 mg/mL), 5-mL fill in a 6-mL vial (NDC 63323-883-05), from batch 6120525 (Exp. 11/20). The product was distributed throughout the United States and Puerto Rico.
Fresenius Kabi voluntarily initiated the recall November 17, 2020. On November 24, 2020, the FDA designated the recall Class III. Under the recall classification, use of the affected product is not likely to cause harm.
Doxorubicin hydrochloride injection is a prescription chemotherapy medication used to treat cancer.