Pacira Pharmaceuticals recalls Zilretta 32mg injectable due to failed dissolution testing at 9 months cold storage followed by 6 weeks at room temperature. Affected units have NDC 65250-003-01 carton and NDC 65250-001-01 vials.
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
Pacira Pharmaceuticals is recalling Zilretta 32mg injectable suspensions because they failed dissolution testing after being stored cold for 9 months and then at room temperature for 6 weeks. This could mean the medication doesn't work properly when used as intended.
The medication failed tests for how well it dissolves in the body after being stored under specific temperature conditions. This could mean the drug doesn't release the active ingredient properly when injected, potentially reducing effectiveness.
Prescription patients who received this specific Zilretta product from Pacira Pharmaceuticals. Patients using the medication for conditions like arthritis or skin inflammation are most at risk.
Check for NDC 65250-003-01 on the carton or NDC 652550-001-01 on the vial. The product was manufactured for Pacira Pharmaceuticals with Lot 23-9006 and expires March 2025.
Look for NDC 65250-003-01 on the carton or NDC 65250-001-01 on the vial to confirm if it's affected.
The recall is due to failed dissolution testing, which may affect effectiveness but does not indicate immediate safety risks. The product is still safe for use as intended if it passes the test.
The recall does not specify a remedy, so you can continue using it if it's within the expiration date and stored properly.
Check the NDC numbers: carton NDC 65250-003-01 and vial NDC 65250-001-01. The product was manufactured with Lot 23-9006 and expires March 2025.
We’ve drafted a message you can send Pacira to request your refund or repair — edit it as you like.
Subject: Recall D-0567-2024 — Pacira Pacira Hello, I own a Pacira that is covered by recall D-0567-2024 from Pacira. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
