Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US... — FDA record D-0186-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 27, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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
Reason
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Classification
Class II
Recalling firm
Eugia US LLC
Quantity
17,300 10-mL vials
Agency-reported status
Ongoing
Source record identifier
D-0186-2025

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What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityBatch # 1PR24010, Expiry: 02/28/2027

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Distributed Nationwide in the USA.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jan 15, 2025
Recall initiation date
Dec 27, 2024
Center classification date
Jan 7, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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