Class III
Terminated
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
- Company
- Flexion Therapeutics, Inc.
- Recall Initiated
- May 19, 2020
- Posted
- July 8, 2020
- Recall Number
- D-1376-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 792 kits
- Firm Location
- Burlington, MA, United States
Reason for Recall
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Distribution
Nationwide within the United States only lots distributed by Besse Medical are affected.
Lot / Code Info
Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
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