Safety Alerts & Recalls

What does this mean?

This recall for Ketotifen Ophthalmic Solution Eye Drops sold under several store brand names was issued at a warehouse and retail level only. The FDA and the manufacturer have determined that any recalled product that consumers may have purchased does not pose a significant health risk. However, if you have any recalled product you may wish to stop using it since solutions with the wrong pH may irritate your eyes. If you have used any of the recalled product and are concerned, you should consult with your doctor or pharmacist.

Itch Relief Eye Drops Recalled from Popular Store Brands (Target, Walgreens, CVS, Kroger, H-E-B and Others)

Pl Developments, Inc. is recalling several lots of Ketotifen Ophthalmic Solution Eye Drops sold over-the-counter (OTC) under several popular store brand names. These lots are being recalled because they measured outside of the acceptable pH range during routine testing and did not meet the manufacturer's quality standards.

The recalled lots are distributed under the brand names listed below. The NDC number is a product code number that is listed on the packaging.

American Fare brand: Eye Itch Relief Drops, NDC 59726-299-12

Careone brand: Eye Itch Relief Drop

CVS brand: Eye Itch Relief Drops, NDC 59726-299-12

Discount Drug Mart brand: Eye Itch Relief Drops, NDC 59726-299-12

Equaline brand: Eye Itch Relief, NDC 59726-299-12

Equate brand: Eye Itch Relief Drops, NDC 49035-299-12

Good Neighbor Pharmacy brand, NDC 24385-0494-64

Goodsense brand: Allergy Itchy Eye Relief Drops, NDC 59726-012-17

H-E-B brand: Eye Itch Relief Drops, NDC 59726-299-12

Kroger brand: Eye Itch Relief Drops, NDC 30142-299-12

Premier Value brand: Eye Itch Relief Drops, NDC 59726-299-12

Rite-Aid brand: Antihistamine Eye Drop

Target brand: Eye Drops Itch Relief, NDC 11673-299-12

TopCare brand: Eye Itch, NDC 59726-299-12

Walgreens brand: Eye Itch Relief; NDC 0363-299-12

The lot numbers recalled include: T0533, T0534, T0647, T0648, T0836, T0837, T0864, T0865, T0944, T1084, U0855, U0856, U1099, U1100, and U1388

No other lots, strengths, formulations, or brands of Ketotifen were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-07-21
Last Updated: 2010-07-23

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