Zilretta recalled over temperature-control failures

Recall date

May 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Flexion Therapeutics, Inc. recalls Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits,…

Recall number

D-1376-2020

FDA classification

Class III

Brand / firm

Flexion Therapeutics, Inc.

Sold / distributed

Nationwide within the United States only lots distributed by Besse Medical are affected.

Why it was recalled

Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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