Oncology Formulations Not Affected by Bevacizumab Recall

September 06, 2019 by Elisa Becze BA, ELS, Editor

On September 3, 2019, AmEx Pharmacy issued a voluntary recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacifico-national-inc-dba-amex-pharmacy-issues-voluntary-nationwide-recall-all-lots-bevacizumab?utm_campaign=FDA%20MedWatch%20-%20Bevacizumab%20by%20Pacifico%20National%20dba%20AmEx%20Pharmacy&utm_medium=email&utm_source=Eloqua) of two dosages of injectable bevacizumab. Although injectable bevacizumab is used in cancer treatment, the formulations affected by the recall are for much smaller dosages that are used to treat eye diseases (i.e., macular degeneration and diabetic retinopathy).

The affected products are bevacizumab 1.25 mg/0.05 ml 31G injectable and bevacizumab 2.5 mg/0.1 ml Normject TB injectable. AmEx Pharmacy is recalling all lots of the two dosages that were distributed across the United States because of sterility concerns.

Dosages typically used in oncology range from 5–15 mg/kg (https://reference.medscape.com/drug/avastin-mvasi-bevacizumab-342257) and are manufactured by Genentech, Amgen (a biosimilar version), and Pfizer (also a biosimilar version). At this time, none of the recalls affect the dosages or formulations from those manufacturers, but oncology nurses should remain vigilant and report any quality concerns with any medications to the U.S. Food and Drug Administration’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.

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