FDA Drug recall D-0567-2024
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceutical…
- FDA Drug
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceutical… by Pacira Pharmaceuticals, citing failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0567-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-12 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pacira Pharmaceuticals |
| Distribution | US |
Product
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 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01
Reason
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Identifiers
| ndc | 65250-003-01 |
|---|---|
| ndc | 65250-001-01 |
| ndc | 65250-002-01 |
| code_info | Lot 23-9006; Expiry Date: MAR 2025 |
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-0567-2024%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.