Drug product
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
D-1376-2020
Product summary
- Event
- Event 85742
- Status
- Terminated
- Classification
- Class III
- Quantity
- 792 kits
- Official record key
drug-enforcement:D-1376-2020
Official wording
Reason: Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Code information: Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
Distribution pattern: Nationwide within the United States only lots distributed by Besse Medical are affected.
Derived failure modes
-
Unknown
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded