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Class II · ModerateRecall completed

Ranitidine Oral Solution

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

Does this affect you?
Check your lot numberLot number: 501290, Expiry: 11/30/19, NDC: [redacted-phone]; Lot number: 501326, Expiry: 11/30/19, NDC: [redacted-phone]; Lot number: 501501, Expiry: 11/30/19, NDC: [redacted-phone]; Lot number: 1592, Expiry: 4/30/20, NDC: [redacted-phone]; Lot number: 501679, Expiry: 4/30/20, NDC: [redacted-phone], [redacted-phone]
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 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 / forPrecision Dose Inc.
NDC68094-204-62
Show the full FDA record
Full product labelRanitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Recalling firmPrecision Dose Inc.
DistributionNationwide USA
Quantity224,940 unit dose cups
Recall initiated2019-11-13
Report date2020-03-18
Recall completed2022-09-17
Recall numberD-1004-2020
ClassificationClass II
FDA statusTerminated
Origin on fileSouth Beloit IL 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.