Drug 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

D-0108-2024

October 31, 2023

Class I

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 93339
Status: Terminated
Classification: Class I
Quantity: 65,880 bottles
Official record key: drug-enforcement:D-0108-2024

Official wording

Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Code information: All lots

Distribution pattern: Nationwide within the United States

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.