FDA recall D-0108-2024

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class I · 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

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

Key facts

Status: Terminated
Initiation date: 2023-10-31
Report date: 2023-11-29
Termination date: 2025-04-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2024