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
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
Lot numbers, UPCs & expiration codes
Lot 23-9006; Expiry Date: MAR 2025
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0567-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 12, 2024
- FDA report date
- Jul 3, 2024
- Quantity
- 40,517 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PACIRA PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0567-2024, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94791
- Address
- 10578 Science Center Dr
- Code information
- Lot 23-9006; Expiry Date: MAR 2025
- Postal code
- 92121-1143
- Report date
- Jul 3, 2024
- Product type
- Drugs
- Recall number
- D-0567-2024
- Classification
- Class II
- Recalling firm
- PACIRA PHARMACEUTICALS INC
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Jun 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2024