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FDARecalled Jun 19, 2024 · #D-0546-2024

Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-0...

Hazard

Class II — temporary health risk

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Description

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. Classification: Class II Distribution: U.S. Nationwide.

Product details

Product
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01.
Type
Drugs
Manufacturer
PACIRA PHARMACEUTICALS INC
Model numbers
082657
UPCs