FDA Recall D-0567-2024

PACIRA PHARMACEUTICALS INC · San Diego, CA

Class II Ongoing 701 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot 23-9006; Expiry Date: MAR 2025

Quantity: 40,517 kits

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

Recall record

Recall number: D-0567-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2024-06-12
Classified by FDA Center: 2024-06-25
FDA published: 2024-07-03
Recalling firm: PACIRA PHARMACEUTICALS INC
Firm location: San Diego, CA

Drug identification

Brand name(s): ZILRETTA
Generic name(s): TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION
Manufacturer(s): Pacira Pharmaceuticals, Inc.
NDC(s): 65250-003
Route(s): INTRA-ARTICULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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