PACIRA PHARMACEUTICALS INC: Drug Recall
Recall #D-0567-2024 · 06/12/2024
Class II: Risk
Recall Details
- Recall Number
- D-0567-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- PACIRA PHARMACEUTICALS INC
- Status
- Ongoing
- Date Initiated
- 06/12/2024
- Location
- San Diego, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,517 kits
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
Product Description
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
Distribution Pattern
US Nationwide.
Other Recalls by PACIRA PHARMACEUTICALS INC
- Class II: Risk 05/07/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.