Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUG...
FDA Recall #D-0107-2024 — Class I — October 31, 2023
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.
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1,271,810 bottles
Distribution
Nationwide within the United States
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated