Drug 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
D-0567-2024
Product summary
- Event
- Event 94791
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40,517 kits
- Official record key
drug-enforcement:D-0567-2024
Official wording
Reason: 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
Code information: Lot 23-9006; Expiry Date: MAR 2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications