The Recall Registry
Recall data checked 6 hours ago

Home Prescription medicine Cardinal Health Inc. — LEADER brand Dry Eye…

Food & drug recall · FDAOctober 31, 2023Highest risk

Cardinal Health Inc. — LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this highest riskFDA Class I: reasonable probability of serious harm or death.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Cardinal Health Inc.

The 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

Details

Units affected
11,782 bottles
Recall date
October 31, 2023
Brand
Cardinal Health Inc.
Model, lot or SKU numbers
ALL LOTS
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Cardinal Health Inc. — 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

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

Other prescription medicine recalls