Drug Enforcement D-0546-2024

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

Status

Ongoing

Classification

Class II

Report Date

June 19, 2024

Termination Date

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Product Information

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.
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide.

Location & Firm

Recalling firm
PACIRA PHARMACEUTICALS INC
Address
10578 Science Center Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0546-2024
Event ID
94568
Recall initiation date
May 7, 2024
Center classification date
June 7, 2024
Code info
Lot: 082657 (kit 23-9004), Exp: July 2024.
More code info
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