Progesterone Injection, Solution
FDA Recall NDC 55150-306
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Progesterone (NDC 55150-306). A significant event, classified as Class II, was initiated on Dec 27, 2024 by Eugia Us Llc. The reported reason for this action was: "Presence of Particulate Matter: A market complaint was received of a glass piece in the vial."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Dec 27, 2024
Jan 15, 2025
17,300 10-mL vials
Recall Profile & Regulatory Data
Event ID
96073
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA.
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
Batch or Lot Expiration Information
Batch# 1PR24010, Expiry: 02/28/2027
Affected Packages Involved in this Recall
55150-306-10Product
Class II Ongoing
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Jul 26, 2024
Aug 07, 2024
17136 vials
Recall Profile & Regulatory Data
Event ID
95059
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# : CPR230029A
Affected Packages Involved in this Recall
55150-306-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
