FDAFDA · Food and drugs·Recall number D-0567-2024
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
Published July 3, 2024 · Recall initiated: June 12, 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 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZILRETTA
- Manufacturer
- PACIRA PHARMACEUTICALS INC
- Distributor
- US Nationwide.
- Lot
- Lot 23-9006; Expiry Date: MAR 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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