Pacira Pharmaceuticals Recalls Zilretta Injectable Suspension for Failed Dissolution Testing
Pacira Pharmaceuticals recalls Zilretta intra-articular injectable suspension nationwide after the product failed dissolution specifications in stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 with failed dissolution specifications indicating formulation instability. The product failed quality testing and poses a potential risk of therapeutic failure or unknown medication stability. No reported illnesses or injuries are documented. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pacira Pharmaceuticals has recalled Zilretta (triamcinolone acetonide extended-release injectable suspension), a corticosteroid medication administered by intra-articular joint injection. The affected product consists of 40,517 kits of 32 mg per vial formulations distributed nationwide.
The recall was initiated because the product failed to meet dissolution specifications during stability testing. Batches from Lot 23-9006 did not meet acceptance criteria for IVR Level 3 testing conducted after nine months of storage at 2-8°C followed by six weeks at 25°C. This indicates the drug formulation may not properly dissolve or release the active ingredient under these conditions.
The recalled product is limited to Lot 23-9006 with an expiration date of March 2025. Patients and healthcare providers with this product should contact Pacira Pharmaceuticals for more information regarding this recall and appropriate follow-up measures.
The recalled product
- Product
- ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION)
- Brand
- ZILRETTA
- Manufacturer
- PACIRA PHARMACEUTICALS INC
- Category
- Drug
- Affected units
- 40,517
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 23-9006
- Expiry Date: MAR 2025
Distribution
Distributed nationwide across the United States.
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