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Class II · ModerateRecall completed

Ranitidine 150 mg tablets

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

Does this affect you?
Check your lot numberP134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
Where it was soldProduct was distributed to one consignee who may have distributed the product further to their retail stores.
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 Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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 / forAAA Pharmaceutical, Inc.
NDC37808-196-04
Show the full FDA record
Full product labelRanitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Recalling firmAAA Pharmaceutical, Inc.
DistributionProduct was distributed to one consignee who may have distributed the product further to their retail stores.
Quantity31,536 (130-count bottles)
Recall initiated2019-12-26
Report date2020-01-15
Recall completed2021-03-10
Recall numberD-0646-2020
ClassificationClass II
FDA statusTerminated
Origin on fileLumberton NJ United States

Related

Ranitidine recallsRecent 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.