Burlington, MA, United States
Flexion Therapeutics, Inc. recalls
1 recall recorded since 2018, most recently on 19 May 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 19 May 2020
- Terminated
- 3 November 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1376-2020
- 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,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.