Drug 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.
D-0041-2024
Product summary
- Firm
- Eugia US LLC
- Event
- Event 93128
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,626 vials
- Official record key
drug-enforcement:D-0041-2024
Official wording
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.
Code information: Lot #: 3TC22010, Exp 11/30/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter