Recalls / Class I
Class ID-0108-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- All lots
Why it was recalled
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 65,880 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-10-31
- FDA classified
- 2023-11-17
- Posted by FDA
- 2023-11-29
- Terminated
- 2025-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0108-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.