FDA Recall D-0624-2024
Eugia US LLC · East Windsor, NJ
Class II Ongoing 657 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Reason for recall
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Recall record
- Recall number
D-0624-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-07-26
- Classified by FDA Center
- 2024-08-01
- FDA published
- 2024-08-07
- Recalling firm
- Eugia US LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- PROGESTERONE
- Generic name(s)
- PROGESTERONE
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-306- Route(s)
- INTRAMUSCULAR
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.