# FDA recall D-0567-2024

> **PACIRA PHARMACEUTICALS INC** · Class II · drug recall initiated 2024-06-12.

## 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

## 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

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0567-2024
- **Recalling firm:** PACIRA PHARMACEUTICALS INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-06-12
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0567-2024

## Citation

> AI Analytics. FDA recall D-0567-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0567-2024. Source: US FDA. Licensed CC0.

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