Why it was recalled
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Product description
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
Lot numbers, UPCs & expiration codes
Batch # 1PR24010, Expiry: 02/28/2027
Where it was sold
Distributed 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-0186-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 27, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 17,300 10-mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0186-2025, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96073
- Address
- 279 Princeton Hightstown Rd
- Code information
- Batch # 1PR24010, Expiry: 02/28/2027
- Postal code
- 08520-1401
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0186-2025
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 17,300 10-mL vials
- Reason for recall
- Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
- Distribution pattern
- Distributed Nationwide in the USA.
- Recall initiation date
- Dec 27, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 7, 2025