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Recall Observatory FDA recall evidence

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

May 19, 2020

Class III

Product summary

Firm
Flexion Therapeutics, Inc.
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

    reason.no_named_rule · v1.0.0

    Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded