CLASS II ONGOING Drug recall · Reported 11 Oct 2023 · FDA Enforcement Report

Triamcinolone Acetonide Injectable Suspension recalled by Eugia US

Eugia US is recalling Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per (40mg/mL) Multiple Dose, distributed nationwide in the US. The recall was initiated on 28 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 3TC22010, Exp 11/30/2024
NDC55150-384, 55150-385
UPC0355150384013, 0355150385010
Quantity recalled1,626 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0041-2024
FDA event ID
93128
Recalling firm
Eugia US, East Windsor, NJ
Manufacturer
Eugia US LLC
Classification
Class II
Status
Ongoing
Recall initiated
28 Sep 2023
FDA classified
5 Oct 2023
Reported
11 Oct 2023
Type
Voluntary: Firm initiated
Customers notified by
N/A
Reason category
Particulate Matter

Timeline

28 Sep 2023Recall initiated by company
5 Oct 2023Classified by FDA+7 days
11 Oct 2023Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Is Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per (40mg/mL) Multiple Dose recalled?

Yes. Eugia US recalled Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per (40mg/mL) Multiple Dose on 28 Sep 2023. The recall is Class II and its status is Ongoing. Recall number D-0041-2024.

Why was it recalled?

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.

Which lots are affected?

Lot #: 3TC22010, Exp 11/30/2024

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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