Reported Jul 3, 2024 · Ongoing
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for:…
Pacira Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PACIRA PHARMACEUTICALS INC · 10578 Science Center Dr · San Diego, CA · 92121-1143
Is this the product you have?
- Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only
- Manufactured forPacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd
- forPacira Pharmaceuticals, Inc. NDC 65250-002-01
- Lot codes and dates
- Lot 23-9006
- Expiry DateMAR 2025
- Amount recalled
- 40,517 kits
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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