Class IIOngoing

Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension… recall

FDA recall D-0546-2024 · initiated May 7, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

Details

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.
Recalling company: Pacira Pharms Inc
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide.
Initiated: May 7, 2024
FDA report date: Jun 19, 2024

This recall is linked to a product we cover: Zilretta →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0546-2024 ↗

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