Recall: D-0041-2024

Class II - Potentially Harmful

Class IIClassification

2023-09-28Initiated

OngoingStatus

Eugia US LLCFirm

Product

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.

Reason

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.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.