Drug Enforcement D-0186-2025

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Status

Ongoing

Classification

Class II

Report Date

January 15, 2025

Termination Date

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Product Information

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
Product quantity
17,300 10-mL vials
Reason for recall
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA.

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0186-2025
Event ID
96073
Recall initiation date
December 27, 2024
Center classification date
January 7, 2025
Code info
Batch # 1PR24010, Expiry: 02/28/2027
More code info
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