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Class II · ModerateActive recall

Sertraline Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 222033, exp. date 08/31/2024
Where it was soldCA and AR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLegacy Pharmaceutical Packaging, LLC
Brand nameSERTRALINE HYDROCHLORIDE
Generic nameSERTRALINE HYDROCHLORIDE
Active ingredient(s)SERTRALINE HYDROCHLORIDE
Distributed by / forWal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045
NDC68645-523-54
Show the full FDA record
Full product labelSertraline 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
Recalling firmLegacy Pharmaceutical Packaging LLC
DistributionCA and AR
Quantity161,664 bottles
Recall initiated2023-12-11
Report date2024-01-03
Recall completed—
Recall numberD-0205-2024
ClassificationClass II
FDA statusOngoing
Origin on fileEarth City MO United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.