September 14, 2018
Citing the potential for superpotency, McKesson Corporation issued a voluntary recall for 1531 cartons of megestrol acetate oral suspension, USP, 400 mg/mL, 10 mL (NDC 63739-549-51). According to the September 12, 2018, US Food and Drug Administration (FDA) Enforcement Report, the affected medication was manufactured by Par Pharmaceutical and distributed within the United States by McKesson Corporation.
The recall affects 10-mL unit dose cups of megestrol acetate oral suspension, packaged in boxes of 20 cups, from lots 0116158 (Exp. 4/30/19), and 0113903, 0113902, and 0113901 (Exp. 8/31/18).
McKesson initiated the recall August 14, 2018. On September 5, 2018, the FDA designated the recall Class II. Drugs included in Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Megestrol acetate oral suspension is a prescription progesterone used to treat patients with anorexia, cachexia, or significant weight loss associated with acquired immunodeficiency syndrome (AIDS). It is also used in the treatment of patients with advanced breast cancer and endometrial cancer.
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