PACIRA PHARMACEUTICALS INC recalls Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Ma
Recalled June 19, 2024 · FDA recall D-0546-2024 · PACIRA PHARMACEUTICALS
Hazard
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. · FDA Class II
Units
43,768 kits
Sold at
U.S. Nationwide.
Description
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
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.
Manufacturer(s)
PACIRA PHARMACEUTICALS INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →