Reported Jul 8, 2020 · Terminated
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits,…
Flexion Therapeutics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flexion Therapeutics, Inc. · 10 Mall Rd Ste 301 · Burlington, MA · 01803-4121
Is this the product you have?
- Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only
- Manufactured for
Flexion TherapeuticsInc. 10 Mall RoadSuite 301BurlingtonMA 01803NDC 70801-003-01
- Lot codes and dates
- Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
- Amount recalled
- 792 kits
Where it was sold
- Nationwide
Why it was recalled
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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