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
Reported: November 29, 2023 Initiated: October 31, 2023 #D-0108-2024
Product Description
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 for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Details
- Units Affected
- 65,880 bottles
- Distribution
- Nationwide within the United States
- Location
- La Vergne, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 65,880 bottles.
Why was this product recalled? ▼
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 29, 2023. Severity: Critical. Recall number: D-0108-2024.
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