Recalls / Class II
Class IID-0041-2024
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.
- Brand name
- Triamcinolone Acetonide
- Generic name
- Triamcinolone Acetonide
- Active ingredient
- Triamcinolone Acetonide
- Route
- Intra-articular, Intramuscular, Soft Tissue
- NDCs
- 55150-384, 55150-385
- FDA application
- ANDA212400
- Affected lot / code info
- Lot #: 3TC22010, Exp 11/30/2024
Why it was 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.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 1,626 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-09-28
- FDA classified
- 2023-10-05
- Posted by FDA
- 2023-10-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0041-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.