FDA-Drug2023-11-29Class I
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Sold states
Nationwide within the United States
Affected count
1,271,810 bottles
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0107-2024Don't want to check this manually?
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