FDA Drug recall D-1376-2020
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufacture…
- FDA Drug
- Class III
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class III recall of Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufacture… by Flexion Therapeutics, citing temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1376-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-05-19 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Flexion Therapeutics |
| Distribution | US |
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
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Identifiers
| code_info | Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1376-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.