Drug Enforcement D-0624-2024

Presence of Particulate Matter: Complaint received of a glass particle in the vial.

Status

Ongoing

Classification

Class II

Report Date

August 7, 2024

Termination Date

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Product Information

Product description
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.
Product quantity
17136 vials
Reason for recall
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd, N/A

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

Codes & Dates

Recall number
D-0624-2024
Event ID
95059
Recall initiation date
July 26, 2024
Center classification date
August 1, 2024
Code info
Lot #: CPR230029A
More code info
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