Drug Enforcement D-0363-2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Status

Ongoing

Classification

Class II

Report Date

April 23, 2025

Termination Date

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Product Information

Product description
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
Product quantity
36,816 vials
Reason for recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0363-2025
Event ID
96680
Recall initiation date
April 10, 2025
Center classification date
April 14, 2025
Code info
Lot #: 1TC24075A, Exp 11/30/2026.
More code info
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