RecallDepth
Class II Ongoing

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.

This recall is currently active, issued June 19, 2024. It was issued by Pacira Pharmaceuticals, Inc..

Company
Pacira Pharmaceuticals, Inc.
Recall Initiated
May 7, 2024
Posted
June 19, 2024
Recall Number
D-0546-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
43,768 kits
Firm Location
San Diego, CA, United States
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

U.S. Nationwide.

Lot / Code Info

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

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