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D-0186-2025Class II

Eugia US LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Eugia US LLC
Product type
Drug
Status
Ongoing
Report date
2025-01-15
Distribution
Distributed Nationwide in the USA.
Firm state
NJ
Product quantity
17,300 10-mL vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Code / lot info

Batch # 1PR24010, Expiry: 02/28/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →