D-0107-2024 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2023
- Initiation Date
- October 31, 2023
- Termination Date
- April 15, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,271,810 bottles
Product Description
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.
Reason for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution Pattern
Nationwide within the United States
Code Information
All lots