Recall

Serious risk

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%,…

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

Official FDA data record

What to do

Does your product match this recall?

Scan your barcode or label to compare your product with this notice. We’ll help you check the lot or date code when needed.

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  1. 1Compare the product, size and lot or date code with this notice.
  2. 2If your product matches, stop using it and follow the official recall instructions.
  3. 3Read the official notice for return, refund or disposal instructions.

Recall details

Firm
Cardinal Health Inc.
Status
Ongoing
Reported
Nov 29, 2023
Started
Oct 31, 2023
Where sold
Nationwide in the USA
Quantity
119,871 bottles
Notice number
D-0135-2024

Lots, UPC, dates

ALL LOTS

Agency wording

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1

Source: FDA OTC report. This is not medical advice. Compare your package codes before you act.