December 2024 FDA Recall Progesterone by Eugia Us Llc
D-0186-2025 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Eugia Us Llc on December 27, 2024 for the product Progesterone. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0186-2025
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
12-27-2024
01-15-2025
17,300 10-mL vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eugia US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Batch# 1PR24010, Expiry: 02/28/2027
