Drug Enforcement D-0041-2024

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.

Status

Ongoing

Classification

Class II

Report Date

October 11, 2023

Termination Date

—

Product Information

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.
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.
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0041-2024
Event ID
93128
Recall initiation date
September 28, 2023
Center classification date
October 5, 2023
Code info
Lot #: 3TC22010, Exp 11/30/2024
More code info
—