FDA Recall D-0041-2024

Eugia US LLC · East Windsor, NJ

Class II Ongoing 959 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

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 record

Recall number: D-0041-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA
Recall initiated: 2023-09-28
Classified by FDA Center: 2023-10-05
FDA published: 2023-10-11
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): TRIAMCINOLONE ACETONIDE
Generic name(s): TRIAMCINOLONE ACETONIDE
Manufacturer(s): Eugia US LLC
NDC(s): 55150-384, 55150-385
Route(s): INTRA-ARTICULAR, INTRAMUSCULAR, SOFT TISSUE

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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