Drug Recall: Triamcinolone Acetonide Injectable Contains Glass Contamination
Eugia US LLC is recalling 1,626 vials of Triamcinolone Acetonide Injectable Suspension due to glass contamination. The affected lot (3TC22010, exp. 11/30/2024) was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Glass contamination in an injectable medication creates a risk of serious injury if administered. Although no illnesses or injuries have been reported, this recall meets the High severity threshold as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Eugia US LLC is recalling Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL across the United States. The recall affects 1,626 vials of the medication, a corticosteroid used for intramuscular or intra-articular injection.
A complaint identified the presence of a piece of glass, approximately 1 cm by 0.5 cm, inside a vial. Glass contamination in an injectable product poses a risk of serious injury if administered to a patient.
The affected product is Lot #3TC22010 with an expiration date of 11/30/2024, distributed nationwide. Consumers and healthcare providers who have received this lot should discontinue use immediately and contact their pharmacy or healthcare provider. The product should not be administered.
The recalled product
- Product
- TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
- Brand
- TRIAMCINOLONE ACETONIDE
- Manufacturer
- Eugia US LLC
- Category
- Drug
- Affected units
- 1,626
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3TC22010
- Exp 11/30/2024
UPCs (2)
- 0355150384013
- 0355150385010
Distribution
Distributed nationwide across the United States.
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