Why it was recalled
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Product description
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01
Lot numbers, UPCs & expiration codes
Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
Where it was sold
Nationwide within the United States only lots distributed by Besse Medical are affected.
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-1376-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 19, 2020
- FDA report date
- Jul 8, 2020
- Quantity
- 792 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Flexion Therapeutics, Inc.
Original FDA data
Every field from FDA enforcement report D-1376-2020, exactly as published.
Show all FDA fields
- City
- Burlington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 85742
- Address
- 10 Mall Rd Ste 301
- Code information
- Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
- Postal code
- 01803-4121
- Report date
- Jul 8, 2020
- Product type
- Drugs
- Recall number
- D-1376-2020
- Classification
- Class III
- Recalling firm
- Flexion Therapeutics, Inc.
- Product quantity
- 792 kits
- Termination date
- Nov 3, 2020
- Reason for recall
- Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01
- Distribution pattern
- Nationwide within the United States only lots distributed by Besse Medical are affected.
- Recall initiation date
- May 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2020