Why it was recalled
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 082657 (kit 23-9004), Exp: July 2024.
Where it was sold
U.S. 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-0546-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 7, 2024
- FDA report date
- Jun 19, 2024
- Quantity
- 43,768 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PACIRA PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0546-2024, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94568
- Address
- 10578 Science Center Dr
- Code information
- Lot: 082657 (kit 23-9004), Exp: July 2024.
- Postal code
- 92121-1143
- Report date
- Jun 19, 2024
- Product type
- Drugs
- Recall number
- D-0546-2024
- Classification
- Class II
- Recalling firm
- PACIRA PHARMACEUTICALS INC
- Product quantity
- 43,768 kits
- Reason for recall
- Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- May 7, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 7, 2024