Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

Recall Number: D-0107-2024

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Classification: Class I

Status: Terminated

Report Date: 20231129

Initiation Date: 20231031

Termination Date: 20250415

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

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.