July 09, 2020
Flexion Therapeutics Inc. is voluntarily recalling a single lot of Zilretta (triamcinolone acetonide extended-release injectable suspension) kits because the product was stored at room temperature longer than 6 weeks, according to the July 8, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Zilretta, 32 mg per vial, 5-mL vials, single-dose kits (NDC 70801-003-01) from lot ZA19014 (Exp. 5/21). The product was distributed throughout the United States.
Flexion Therapeutics initiated the recall May 19, 2020. The FDA has not yet classified the recall.
Available with a prescription, Zilretta is an extended-release corticosteroid approved to manage osteoarthritis knee pain.