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Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx onl...

FDA Recall #D-0567-2024 — Class II — June 12, 2024

Recall #D-0567-2024 Date: June 12, 2024 Classification: Class II Status: Ongoing

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

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

Recalling Firm

PACIRA PHARMACEUTICALS INC — San Diego, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

40,517 kits

Distribution

US Nationwide.

Code Information

Lot 23-9006; Expiry Date: MAR 2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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