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Class II · ModerateRecall completed

Equate Maximum Strength Ranitidine Tablets

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

Does this affect you?
Check your lot numberAll lots remaining within expiry.
Where it was soldNationwide
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

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

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

Distributed by / forWal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack
NDC49035-100-07
Show the full FDA record
Full product labelEquate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
Recalling firmApotex Inc.
DistributionNationwide
Quantity1,132,453 bottles
Recall initiated2019-09-24
Report date2019-11-20
Recall completed—
Recall numberD-0316-2020
ClassificationClass II
FDA statusCompleted
Origin on fileNorth York N/A Canada

Related

Ranitidine recallsRecent drug recallsCheck another medication

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.