Drug Recall: 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 65
PACIRA PHARMACEUTICALS INC · June 12, 2024
Reason for Recall
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 Description
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
Distribution
US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
40,517 kits
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0567-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.