Flexion Recalls Zilretta Injectable Suspension Due to Temperature Abuse
Flexion Therapeutics is recalling 792 kits of Zilretta (triamcinolone acetonide) because the product was stored at room temperature for more than six weeks.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a storage error (temperature abuse) rather than a contamination or manufacturing defect that poses an immediate high risk.
Plain-English summary
Flexion Therapeutics, Inc. is recalling 792 single-dose kits of Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials. The recall affects Lot ZA19014 with an expiration date of 05/2021. The product is distributed nationwide within the United States, but only the specific lot distributed by Besse Medical is affected.
The recall was initiated because the product was stored at room temperature for longer than six weeks and was inadvertently distributed instead of being discarded. This temperature abuse may compromise the quality and stability of the medication.
Healthcare providers and patients should stop using the affected product. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal.
The recalled product
- 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
- Manufacturer
- Flexion Therapeutics, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 792
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: ZA19014
Distribution
Distributed nationwide across the United States.
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