May 2024 FDA Recall Zilretta by Pacira Pharmaceuticals Inc
D-0546-2024 - Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

This Class II drug recall was voluntarily initiated by Pacira Pharmaceuticals Inc on May 7, 2024 for the product Zilretta. The FDA reported the reason for recall as failed stability specifications - at 12 months 2-8 degrees c followed by 6 weeks at 25 degrees c.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0546-2024

Reason for Recall
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Initiated
05-07-2024
Reported
06-19-2024
Quantity
43,768 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94568
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.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

65250-003-01 Zilretta