Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.
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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.