FDAClass IIJuly 3, 2024

Zilretta recall: Failed Dissolution

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San…

Why was Zilretta recalled?

Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 23-9006; Expiry Date: MAR 2025

Product
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San…
Recalling firm
PACIRA PHARMACEUTICALS INC
Quantity
40,517 kits
Distribution
US Nationwide.
Recall date
July 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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