FDA recall D-0567-2024

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

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

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