Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 m...
FDA Recall #D-0546-2024 — Class II — May 7, 2024
Product Description
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.
Recalling Firm
PACIRA PHARMACEUTICALS INC — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
43,768 kits
Distribution
U.S. Nationwide.
Code Information
Lot: 082657 (kit 23-9004), Exp: July 2024.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated