Eugia US LLC: Drug Recall

Recall Details

Recall Number

D-0041-2024

Classification

Class II

Product Type

Drug

Recalling Firm

Eugia US LLC

Status

Ongoing

Date Initiated

09/28/2023

Location

East Windsor, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,626 vials

Reason for Recall

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.

Product Description

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Eugia US LLC

• Class II: Risk 05/29/2025
  Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
• Class II: Risk 04/21/2025
  Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
• Class II: Risk 04/21/2025
  Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
• Class II: Risk 04/10/2025
  cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
• Class II: Risk 12/27/2024
  Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

View all recalls by Eugia US LLC →