Class I
Terminated
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
This recall has been terminated (originally issued November 29, 2023).
- Recall Initiated
- October 31, 2023
- Posted
- November 29, 2023
- Recall Number
- D-0108-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 65,880 bottles
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution
Nationwide within the United States
Lot / Code Info
All lots
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