PACIRA PHARMACEUTICALS INC: Drug Recall

Recall Details

Recall Number

D-0546-2024

Classification

Class II

Product Type

Drug

Recalling Firm

PACIRA PHARMACEUTICALS INC

Status

Ongoing

Date Initiated

05/07/2024

Location

San Diego, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

43,768 kits

Reason for Recall

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

Product Description

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.

Distribution Pattern

U.S. Nationwide.

Other Recalls by PACIRA PHARMACEUTICALS INC

• Class II: Risk 06/12/2024
  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

View all recalls by PACIRA PHARMACEUTICALS INC →