Drug Enforcement D-0293-2024

Non-Sterility

Status

Ongoing

Classification

Class I

Report Date

February 14, 2024

Termination Date

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Product Information

Product description
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
Product quantity
1,492,344 bottles
Reason for recall
Non-Sterility
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Kilitch Healthcare India Limited
Address
R - 904 905 T T C Industrial Road

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0293-2024
Event ID
93357
Recall initiation date
November 13, 2023
Center classification date
February 5, 2024
Code info
All lots
More code info
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