Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for
Summary
The FDA issued a Class II for Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, by Legacy Pharmaceutical Packaging LLC. Reason: CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product..
Details
Source
Drug Recall
External ID
D-0205-2024
Action Date
2024-01-03
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 222033, exp. date 08/31/2024
Quantity Affected: 161,664 bottles
Reason for Recall
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Distribution
CA and AR
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-11
Company
Earth City, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 74 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Legacy Pharmaceutical Packaging LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Legacy Pharmaceutical Packaging LLC have FDA actions?
This is the only FDA action we have on record for Legacy Pharmaceutical Packaging LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0205-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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