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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: 8AE1884, 8BE1466, 8DE1318, 8CE1617, 8DE1319, 8EE1326, 8DE1611, 8DE1767, 8FE1350, 8FE1352, 8GE1736, 8GE1840, 8GE1859, 8HE1592, 8HE1593, 8HE1594, 8JE2234, 9CE3263, 8JE2233, 8LE2360, 8KE2704, 8ME2641, 8ME2642, 9AE2675, 9AE2676, 9CE3265, 9CE3881, 9DE2585, 9EE2501, 9EE2502, 9FE2825, 9FE2827, 9GE2657, 9GE3124, 9GE3122, 9HE3555
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, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09
Recalling firmPerrigo Company PLC
DistributionNationwide USA
Recall initiated2019-10-23
Report date2020-03-25
Recall completed2020-11-06
Recall numberD-1023-2020
ClassificationClass II
FDA statusTerminated
Origin on fileAllegan MI United States

Related

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.