Drug product

LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1

D-0135-2024

October 31, 2023

Class I

Product summary

Firm: Cardinal Health Inc.
Event: Event 93346
Status: Ongoing
Classification: Class I
Quantity: 11,782 bottles
Official record key: drug-enforcement:D-0135-2024

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.