The Recall Registry
Recall data checked 5 hours ago

Home Over-the-counter & supplements Cardinal Health Inc. — Children's Loratadine…

Food & drug recall · FDAMarch 15, 2021Serious

Cardinal Health Inc. — Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

Check whether yours is affected, then follow the instructions below.

What’s wrong

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have, and follow the FDA recall notice for what to do with the affected product. If you use it daily, or it is for a child, your pharmacist can tell you whether it matters and what to use instead.

Who to contact: Recalling firm: Cardinal Health Inc.

The product

Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

Details

Units affected
2907 bottles
Recall date
March 15, 2021
Brand
Cardinal Health Inc.
Model, lot or SKU numbers
All Lots distributed 02/23/2021 through 03/10/2021.
Where it was distributed

FL, GA, SC

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. — Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

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: Over-the-counter & supplements

Other over-the-counter & supplements recalls