FDAClass IIOctober 13, 2021

Meclizine HCl Tablets recall: Labeling Error

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

Why was Meclizine HCl Tablets recalled?

Labeling: Incorrect Instructions

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 # CB21024, Exp 2/2023

Product
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Recalling firm
RISING PHARMACEUTICALS
Quantity
1,344 bottles
Distribution
to be entered
Recall date
October 13, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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