Drug Enforcement D-0377-2024

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

March 20, 2024

Termination Date

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Product Information

Product description
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
Product quantity
9,936 bottles
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product distributed Nationwide in the USA

Location & Firm

Recalling firm
Optikem International, Inc.
Address
2172 S Jason St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0377-2024
Event ID
94145
Recall initiation date
February 29, 2024
Center classification date
March 12, 2024
Code info
Lot #: C303, Exp: 07-27-2025
More code info
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