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Class II · ModerateRecall completed

Regular Strength Acid Reducer

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

Does this affect you?
Check your lot numberLots: 8DE1367, 8EE1559, 8FE1451, 8GE1340, 8HE1222, 8KE2831, 8JE1917, 8KE2245 , 8ME2724, 9AE2831, 9DE2747, 9CE3339, 9EE2636, 9FE2971, 9GE2793, 9GE3220
Where it was soldNationwide USA
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 Deviation; Possible contamination with impurity N-nitrosodimethylamine.

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 / forPerrigo Company PLC
Show the full FDA record
Full product labelRegular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;
Recalling firmPerrigo Company PLC
DistributionNationwide USA
Recall initiated2019-10-23
Report date2020-03-25
Recall completed2020-11-06
Recall numberD-1013-2020
ClassificationClass II
FDA statusTerminated
Origin on fileAllegan MI United States

Related

Recent 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.