Drug Enforcement D-0205-2024

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

Status

Ongoing

Classification

Class II

Report Date

January 3, 2024

Termination Date

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Product Information

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
Product quantity
161,664 bottles
Reason for recall
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
CA and AR

Location & Firm

Recalling firm
Legacy Pharmaceutical Packaging LLC
Address
13333 Lakefront Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0205-2024
Event ID
93605
Recall initiation date
December 11, 2023
Center classification date
December 26, 2023
Code info
Lot #: 222033, exp. date 08/31/2024
More code info
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