FDARecalled Nov 29, 2023 · #D-0107-2024
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.
Hazard
Class I — serious health risk
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Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Classification: Class I Distribution: Nationwide within the United States
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Model numbers
- —
- UPCs
- —