Status
Ongoing
Drug Enforcement D-0567-2024
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
Classification
Class II
Report Date
July 3, 2024
Termination Date
—
Product Information
- 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
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide.
Location & Firm
- Recalling firm
- PACIRA PHARMACEUTICALS INC
- Address
-
10578 Science Center Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0567-2024
- Event ID
- 94791
- Recall initiation date
- June 12, 2024
- Center classification date
- June 25, 2024
- Code info
- Lot 23-9006; Expiry Date: MAR 2025
- More code info
- —