PACIRA PHARMACEUTICALS INC recalls Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: P…

Recall date

June 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0567-2024

FDA classification

Class II

Brand / firm

PACIRA PHARMACEUTICALS INC

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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