Zilretta — Class III drug recall D-1376-2020
Terminated recall by Flexion Therapeutics, Inc., reported 2020-07-08, distributed nationwide. Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distribute
| Recall number | D-1376-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flexion Therapeutics, Inc., Burlington, MA, United States |
| Recall initiated | 2020-05-19 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2020-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 792 kits |
| Reason classes | temperature control |
| NDC | 70801-0003-01 |
| Lot numbers | ZA19014 |
| Expiration dates | 2021-05 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1376-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.