D-1376-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2020
- Initiation Date
- May 19, 2020
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 792 kits
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
Reason for Recall
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Distribution Pattern
Nationwide within the United States only lots distributed by Besse Medical are affected.
Code Information
Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.