Drug Enforcement D-0366-2024

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

March 13, 2024

Termination Date

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Product Information

Product description
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Product quantity
10,080 vials
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
OH, TN, LA, MS

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-0366-2024
Event ID
94075
Recall initiation date
February 20, 2024
Center classification date
March 4, 2024
Code info
Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
More code info
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