Drug product
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: 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.
D-0546-2024
Product summary
- Event
- Event 94568
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43,768 kits
- Official record key
drug-enforcement:D-0546-2024
Official wording
Reason: Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Code information: Lot: 082657 (kit 23-9004), Exp: July 2024.
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications