December 2023 FDA Recall Sertraline Hydrochloride by Legacy Pharmaceutical Packaging Llc
D-0205-2024 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Legacy Pharmaceutical Packaging Llc on December 11, 2023 for the product Sertraline Hydrochloride. The FDA reported the reason for recall as cgmp deviations. The product was distributed in CA and AR and the recall is currently ongoing.

Recall Number: D-0205-2024

Reason for Recall
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Initiated
12-11-2023
Reported
01-03-2024
Quantity
161,664 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93605
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Legacy Pharmaceutical Packaging LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA and AR
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

68645-521-54 Sertraline Hydrochloride
68645-522-54 Sertraline Hydrochloride
68645-523-54 Sertraline Hydrochloride