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
Reported: July 8, 2020 Initiated: May 19, 2020 #D-1376-2020
Product Description
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
Details
- Recalling Firm
- Flexion Therapeutics, Inc.
- Units Affected
- 792 kits
- Distribution
- Nationwide within the United States only lots distributed by Besse Medical are affected.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Flexion Therapeutics, Inc.. Units affected: 792 kits.
Why was this product recalled? ▼
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 8, 2020. Severity: Low. Recall number: D-1376-2020.
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