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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: 8AE1291, 8AE1785, 8BE1415, 8CE1525, 8DE1201, 8DE1741, 8EE1323, 8FE1806, 8GE1965, 8HE1517, 8JE2161, 8KE2565, 8LE2261, 8ME2548, 9AE2658, 9BE3018, 9CE3861, 9DE3244, 9FE2820, 9FE3373, 9GE3094, 9HE3449, 9JE2665
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, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
Recalling firmPerrigo Company PLC
DistributionNationwide USA
Recall initiated2019-10-23
Report date2020-03-25
Recall completed2020-11-06
Recall numberD-1028-2020
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.