Sertraline Hydrochloride Tablet
FDA Recall NDC 68645-521
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sertraline Hydrochloride (NDC 68645-521). A significant event, classified as Class II, was initiated on Dec 11, 2023 by Legacy Pharmaceutical Packaging, Llc. The reported reason for this action was: "CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Dec 11, 2023
Jan 03, 2024
161,664 bottles
Recall Profile & Regulatory Data
Event ID
93605
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Legacy Pharmaceutical Packaging LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
CA and AR
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
Batch or Lot Expiration Information
Lot# : 222033, exp. date 08/31/2024
Affected Packages Involved in this Recall
68645-521-54Product
68645-522-54Product
68645-523-54Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
