Zilretta (triamcinolone acetonide extended-release injectable suspension) recall
FDA recall D-0567-2024 · initiated Jun 12, 2024
PACIRA PHARMACEUTICALS INC recalled Zilretta (triamcinolone acetonide extended-release injectable suspension) in Jun 2024 — an FDA Class II recall (D-0567-2024) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 40,517 kits
Details
- 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
- Recalling company
- Pacira Pharms Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jun 12, 2024
- FDA report date
- Jul 3, 2024
This recall is linked to a product we cover: Zilretta →
Frequently asked
- Was Zilretta (triamcinolone acetonide extended-release injectable suspension) recalled?
- PACIRA PHARMACEUTICALS INC recalled Zilretta (triamcinolone acetonide extended-release injectable suspension) in Jun 2024 — an FDA Class II recall (D-0567-2024) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Zilretta (triamcinolone acetonide extended-release injectable suspension) recalled?
- Per the FDA enforcement record, the reason for recall D-0567-2024 was: 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
- Is a recalled Zilretta (triamcinolone acetonide extended-release injectable suspension) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Zilretta (triamcinolone acetonide extended-release injectable suspension) are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot 23-9006; Expiry Date: MAR 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0567-2024.