Why it was recalled
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Product description
Progesterone Injection, USP, 500 mg 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
Lot #: CPR230029A
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-0624-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 26, 2024
- FDA report date
- Aug 7, 2024
- Quantity
- 17136 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0624-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95059
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: CPR230029A
- Postal code
- 08520-1401
- Report date
- Aug 7, 2024
- Product type
- Drugs
- Recall number
- D-0624-2024
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 17136 vials
- Reason for recall
- Presence of Particulate Matter: Complaint received of a glass particle in the vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Progesterone Injection, USP, 500 mg 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
- Nationwide in the USA
- Recall initiation date
- Jul 26, 2024
- Center classification date
- Aug 1, 2024