FDAClass IIINovember 17, 2021

Cetirizine hydrochloride recall: Labeling Error

Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3

Why was Cetirizine hydrochloride recalled?

Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 1256330

Product
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
Recalling firm
A-S Medication Solutions LLC.
Quantity
72 bottles
Distribution
FL, IN, MN, WI
Recall date
November 17, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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