Drug recall D-0546-2024

Class II Ongoing reported Jun 19, 2024

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.

Reason for recall

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

Lots and codes

Lot: 082657 (kit 23-9004), Exp: July 2024.

Recall details

Recalling firm
PACIRA PHARMACEUTICALS INC, San Diego, CA
Quantity
43,768 kits
Distribution
U.S. Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
May 7, 2024

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