Class II
Ongoing
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.
This recall is currently active, issued October 11, 2023. It was issued by Eugia Us Llc.
- Company
- Eugia Us Llc
- Recall Initiated
- September 28, 2023
- Posted
- October 11, 2023
- Recall Number
- D-0041-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,626 vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 3TC22010, Exp 11/30/2024
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