May 2020 FDA Recall Drug by Flexion Therapeutics, Inc.
D-1376-2020 - Temperature Abuse

This Class III drug recall was voluntarily initiated by Flexion Therapeutics, Inc. on May 19, 2020 for the product Drug. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1376-2020

Reason for Recall
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Initiated
05-19-2020
Reported
07-08-2020
Quantity
792 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85742
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Flexion Therapeutics, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States only lots distributed by Besse Medical are affected.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-03-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.