June 2024 FDA Recall Zilretta by Pacira Pharmaceuticals Inc
D-0567-2024 - 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

This Class II drug recall was voluntarily initiated by Pacira Pharmaceuticals Inc on June 12, 2024 for the product Zilretta. The FDA reported the reason for recall as 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. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0567-2024

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
Initiated
06-12-2024
Reported
07-03-2024
Quantity
40,517 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94791
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PACIRA PHARMACEUTICALS INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 23-9006; Expiry Date: MAR 2025

Affected Packages Involved in this Recall

65250-003-01 Zilretta