Reported Jun 19, 2024 · Ongoing

Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only,…

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?

  • Drug Vial LabelZilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only
  • Manufactured forPacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01
  • Diluent Vial LabelDiluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01
  • Carton LabelDrug
  • Vial LabelZilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only
  • Manufactured forPacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01
Lot codes and dates
  • Lot082657 (kit 23-9004)
  • ExpJuly 2024
Amount recalled
43,768 kits

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:23 PM UTC

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