Zilretta Injectable Drug Recalled for Failed Stability Specifications
Pacira Pharmaceuticals is recalling 43,768 kits of Zilretta injectable suspension due to failed stability specifications at 2–8°C storage for 12 months followed by 25°C for 6 weeks. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard—failed stability specifications—is theoretical; the drug may lose potency or develop degradation, but no actual harm has been reported. Per the rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Pacira Pharmaceuticals Inc. is recalling 43,768 kits of Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, distributed throughout the United States. The affected product is lot 082657 (kit 23-9004) with an expiration date of July 2024.
The recall was initiated due to failed stability specifications when the product was tested under storage conditions of 2–8°C for 12 months followed by 6 weeks at 25°C. Failed stability testing means the drug may not maintain its intended potency, purity, or safety characteristics. The FDA classified this as a Class II recall.
Patients who received injections from this lot should contact their healthcare provider to discuss any concerns. Healthcare providers should take steps to identify and quarantine product from this lot.
No illnesses or injuries have been reported in association with this recall at this time.
The recalled product
- Product
- ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION)
- Brand
- ZILRETTA
- Manufacturer
- PACIRA PHARMACEUTICALS INC
- Category
- Drug
- Hazard
- failed-stability
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 (2)
- Lot: 082657 (kit 23-9004)
- Exp: July 2024.
Distribution
Distributed nationwide across the United States.
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