Drug 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

D-0132-2024

October 31, 2023

Class I

Product summary

Firm: Cardinal Health Inc.
Event: Event 93346
Status: Ongoing
Classification: Class I
Quantity: 21,802 bottles
Official record key: drug-enforcement:D-0132-2024

Official wording

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

Code information: ALL LOTS

Distribution pattern: Nationwide in the USA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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