Corticosteroid Injection Recalled

Pacira Pharmaceuticals Inc. is recalling 43 768 kits of Zilretta (triamcinolone acetonide extended-release injectable suspension) for failing stability testing, according to the June 19, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Zilretta kits (NDC 65250-003-01) containing Zilretta 32 mg (NDC 65250-001-01) and diluent 5 mL (NDC 65250-002-01) from lot 082657 (kit 23-9004) (Exp. 7/24). The kits were manufactured for Pacira Pharmaceuticals, San Diego, California, and were distributed throughout the United States.

Pacira Pharmaceuticals voluntarily initiated the recall on May 7, 2024. On June 7, 2024, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Zilretta is a prescription corticosteroid injection used to manage osteoarthritis knee pain.