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

FDA recall notice · announced July 8, 2020 · Flexion Therapeutics

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

Reason for recall

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

Notes

Distribution: Nationwide within the United States only lots distributed by Besse Medical are affected.
Lot/code information: Lot #: ZA19014, exp. date 05/2021 Only the specific lot distributed by Besse Medical are affected.
Quantity: 792 kits
Status: Terminated
Products in this recall event:
- 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, Bu (D-1376-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.