Recalls / Class II
Class IID-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
- 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 23-9006; Expiry Date: MAR 2025
Why it was recalled
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
Recalling firm
- Firm
- PACIRA PHARMACEUTICALS INC
- Manufacturer
- Pacira Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10578 Science Center Dr, San Diego, California 92121-1143
Distribution
- Quantity
- 40,517 kits
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2024-06-12
- FDA classified
- 2024-06-25
- Posted by FDA
- 2024-07-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0567-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.