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Class II · ModerateRecall completed

Maximum Strength Acid Reducer

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

Does this affect you?
Check your lot numberLots:8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, 9GE3144
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 labelMaximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
Recalling firmPerrigo Company PLC
DistributionNationwide USA
Recall initiated2019-10-23
Report date2020-03-25
Recall completed2020-11-06
Recall numberD-1025-2020
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.