Recalls / Class II
Class IID-0546-2024
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.
- Brand name
- Zilretta
- Generic name
- Triamcinolone Acetonide Extended-release Injectable Suspension
- Route
- Intra-articular
- NDC
- 65250-003
- FDA application
- NDA208845
- Affected lot / code info
- Lot: 082657 (kit 23-9004), Exp: July 2024.
Why it was recalled
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Recalling firm
- Firm
- PACIRA PHARMACEUTICALS INC
- Manufacturer
- Pacira Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10578 Science Center Dr, N/A, San Diego, California 92121-1143
Distribution
- Quantity
- 43,768 kits
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2024-05-07
- FDA classified
- 2024-06-07
- Posted by FDA
- 2024-06-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0546-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.