PACIRA PHARMACEUTICALS INC recalls Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pa
Recalled July 3, 2024 · FDA recall D-0567-2024 · PACIRA PHARMACEUTICALS
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 · FDA Class II
Units
40,517 kits
Sold at
US Nationwide.
Description
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
Product
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
Manufacturer(s)
PACIRA PHARMACEUTICALS INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →