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
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Class I Recall | MedicineWatch US