FDA recall D-1376-2020

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-05-19

Report date

2020-07-08

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1376-2020