Drug recall D-0132-2024

Class I Ongoing reported Nov 29, 2023

Product

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1

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
21,802 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
October 31, 2023

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