FDAFDA · Food and drugs·Recall number D-0546-2024
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.
Published June 19, 2024 · Recall initiated: May 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZILRETTA
- Manufacturer
- PACIRA PHARMACEUTICALS INC
- Distributor
- U.S. Nationwide.
- Lot
- Lot: 082657 (kit 23-9004), Exp: July 2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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