Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign substance - potential presence of metal particulate matter
Reason Presence of Foreign substance - potential presence of metal particulate matter
Reason Presence of Foreign substance - potential presence of metal particulate matter
Reason Presence of particulate matter - Glass like particles.
Reason CGMP Deviations: Potential presence of metal particulate matter
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