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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: 8CE1644, 8CE1645, 8DE1401, 8DE1402, 8DE1403, 8DE1769, 8DE1773, 8EE1561, 8EE1562, 8FE1453, 8FE1454, 8GE1342, 8HE1224, 8KE2248, 8KE2833, 8JE1918, 8KE2247, 8ME2727, 8ME2729, 9DE2750, 9AE2836, 9AE2837, 9CE3403, 9CE3404, 9DE2749, 9EE2638, 9FE2977, 9GE2796, 9GE3229
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, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
Recalling firmPerrigo Company PLC
DistributionNationwide USA
Recall initiated2019-10-23
Report date2020-03-25
Recall completed2020-11-06
Recall numberD-1015-2020
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.