FDAFDA · Food and drugs·Recall number D-1376-2020
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
Published July 8, 2020 · Recall initiated: May 19, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Flexion Therapeutics, Inc.
- Distributor
- Nationwide within the United States only lots distributed by Besse Medical are affected.
- Lot
- Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.