FDA-Drug2020-07-08Class III
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
Flexion Therapeutics, Inc.
Hazard
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Sold states
Nationwide within the United States only lots distributed by Besse Medical are affected.
Affected count
792 kits
Manufactured in
10 Mall Rd Ste 301, N/A, Burlington, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1376-2020Don't want to check this manually?
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