Flexion Therapeutics, Inc. recalls Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits,
Recalled July 8, 2020 · FDA recall D-1376-2020 · Flexion Therapeutics
Hazard
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded · FDA Class III
Units
792 kits
Sold at
Nationwide within the United States only lots distributed by Besse Medical are affected.
Description
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Product
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01
Manufacturer(s)
Flexion Therapeutics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →