FDA Drug recall D-0546-2024
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pac…
- FDA Drug
- Class II
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pac… by Pacira Pharmaceuticals, citing failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0546-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-07 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pacira Pharmaceuticals |
| Distribution | US |
Product
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01.
Reason
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Identifiers
| ndc | 65250-003-01 |
|---|---|
| ndc | 65250-001-01 |
| ndc | 65250-002-01 |
| code_info | Lot: 082657 (kit 23-9004), Exp: July 2024. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0546-2024%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.