PROGESTERONE Recall D-0186-2025
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
PROGESTERONE Recall D-0186-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0186-2025 |
| Event ID | 96073 |
| Brand | PROGESTERONE |
| Generic Name | PROGESTERONE |
| Manufacturer | PROGESTERONE |
| Original Package? | 1 |
| Active Substance | PROGESTERONE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Distributed Nationwide in the USA. |
| Quantity | 17,300 10-mL vials |
| Recall Reason | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. |
| Drug Classification | Class II |
| Drug Code Info | 20250115 |
| Product NDC | 55150-306 |
| Product NUI | M0017672 N0000175601 |
| Pharma Class (EPC) | Progesterone [EPC] |
| Pharma Class (CS) | Progesterone [CS] |
| Recall Initiation Date | 20241227 |
| Report Date | 20250115 |
| Classification Date | 20250107 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Eugia US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4G7DS2Q64Y |
| Drug Application Number | ANDA210965 |
| Structured Product Labeling (SPL ID) | 44ca9ab1-7336-4914-b059-79559747ac39 |
| Structured Product Labeling (SPL Set ID) | 7d19df3b-94ed-4681-beae-9caaf137d014 |
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