Drug recall D-0134-2024

Class I Ongoing reported Nov 29, 2023

Product

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)

Reason for recall

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Lots and codes

ALL LOTS

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
28477 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
October 31, 2023

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