Drug Vial Label: Zilretta¿ — Class II drug recall D-0546-2024
Ongoing recall by PACIRA PHARMACEUTICALS INC, reported 2024-06-19, distributed nationwide. Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
| Recall number | D-0546-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PACIRA PHARMACEUTICALS INC, San Diego, CA, United States |
| Recall initiated | 2024-05-07 |
| Classified | 2024-06-07 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 43,768 kits |
| Reason classes | specification failure |
| NDC | 65250-0001-01, 65250-0002-01, 65250-0003, 65250-0003-01 |
| Lot numbers | 082657 |
| Expiration dates | 2024-07-20 |
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 for recall
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
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-0546-2024. 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.