FDAClass IIJanuary 3, 2024

Sertraline Tablets recall: CGMP Deviations

Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54

Why was Sertraline Tablets recalled?

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

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 #: 222033, exp. date 08/31/2024

Product
Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54
Recalling firm
Legacy Pharmaceutical Packaging LLC
Quantity
161,664 bottles
Distribution
CA and AR
Recall date
January 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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