FDA Recall D-0546-2024

PACIRA PHARMACEUTICALS INC · San Diego, CA

Class II Ongoing 737 days on record

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

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.

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

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.

Recall record

Recall number: D-0546-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide.
Recall initiated: 2024-05-07
Classified by FDA Center: 2024-06-07
FDA published: 2024-06-19
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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