← FDA ENFORCEMENT
D-0132-2024Class I

Cardinal Health Inc.

Recalling firm
Cardinal Health Inc.
Product type
Drug
Status
Ongoing
Report date
2023-11-29
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
21,802 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

ALL LOTS

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.