Medroxyprogesterone Acetate Injection, Suspension
FDA Recall NDC 55150-330
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Medroxyprogesterone Acetate (NDC 55150-330). A significant event, classified as Class II, was initiated on Dec 18, 2024 by Eugia Us Llc. The reported reason for this action was: "CGMP Deviations"
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
CGMP Deviations
Dec 18, 2024
Jan 15, 2025
19872 vials
Recall Profile & Regulatory Data
Event ID
96018
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India
Batch or Lot Expiration Information
Lot# Lot No.: 1MP24069, Exp.: 08/2026
Affected Packages Involved in this Recall
55150-329-01Product
55150-329-25Product
55150-330-01Product
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.
