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.
Product description
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 numbers, UPCs & expiration codes
Lot #: 3TC22010, Exp 11/30/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0041-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 28, 2023
- FDA report date
- Oct 11, 2023
- Quantity
- 1,626 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0041-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93128
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 3TC22010, Exp 11/30/2024
- Postal code
- 08520-1401
- Report date
- Oct 11, 2023
- Product type
- Drugs
- Recall number
- D-0041-2024
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 28, 2023
- Center classification date
- Oct 5, 2023