FDA Recall D-0205-2024

Legacy Pharmaceutical Packaging LLC · Earth City, MO

Class II Ongoing 885 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 161,664 bottles

Reason for recall

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

Recall record

Recall number: D-0205-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: CA and AR
Recall initiated: 2023-12-11
Classified by FDA Center: 2023-12-26
FDA published: 2024-01-03
Recalling firm: Legacy Pharmaceutical Packaging LLC
Firm location: Earth City, MO

Drug identification

Brand name(s): SERTRALINE HYDROCHLORIDE
Generic name(s): SERTRALINE HYDROCHLORIDE
Manufacturer(s): Legacy Pharmaceutical Packaging, LLC
NDC(s): 68645-521, 68645-522, 68645-523
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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