Drug recall D-0567-2024

Class II Ongoing reported Jul 3, 2024

Product

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 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01

Reason for recall

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

Lots and codes

Lot 23-9006; Expiry Date: MAR 2025

Recall details

Recalling firm
PACIRA PHARMACEUTICALS INC, San Diego, CA
Quantity
40,517 kits
Distribution
US Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
June 12, 2024

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