Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pa
Summary
The FDA issued a Class II for Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg by PACIRA PHARMACEUTICALS INC. Reason: 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.
Details
Source
Drug Recall
External ID
D-0567-2024
Action Date
2024-07-03
Status
Ongoing
Category
drug
Product Description
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 Info: Lot 23-9006; Expiry Date: MAR 2025
Quantity Affected: 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
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-12
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PACIRA PHARMACEUTICALS INC has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PACIRA PHARMACEUTICALS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PACIRA PHARMACEUTICALS INC have FDA actions?
PACIRA PHARMACEUTICALS INC has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0567-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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