Drug 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
Lots and codes
Lot 23-9006; Expiry Date: MAR 2025
Recall details
- Recalling firm
- PACIRA PHARMACEUTICALS INC, San Diego, CA
- Quantity
- 40,517 kits
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 12, 2024
Related products
- Zilretta – drug information
- NDC 65250-003 Zilretta · · Pacira Pharmaceuticals, Inc.