# FDA recall D-1376-2020

> **Flexion Therapeutics, Inc.** · Class III · drug recall initiated 2020-05-19.

## 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

- **Recall number:** D-1376-2020
- **Recalling firm:** Flexion Therapeutics, Inc.
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1376-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1376-2020. Source: US FDA. Licensed CC0.

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