The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Product
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Classification
Class I
Status
Terminated
Lot
All lots
Date
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