D-0567-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 3, 2024
- Initiation Date
- June 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,517 kits
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
Distribution Pattern
US Nationwide.
Code Information
Lot 23-9006; Expiry Date: MAR 2025