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Class II · ModerateRecall completed

Preferred Pharmaceuticals

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

Does this affect you?
Check your lot numberLot #: All lots within expiry
Where it was soldDistribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
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: Presence of NDMA impurity detected in product.

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 / forPreferred Pharmaceuticals, Inc
NDC68788-6382-1
Show the full FDA record
Full product labelPreferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
Recalling firmPreferred Pharmaceuticals, Inc
DistributionDistribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Quantity39,172 tablets
Recall initiated2020-01-07
Report date2020-01-29
Recall completed2023-12-14
Recall numberD-0797-2020
ClassificationClass II
FDA statusTerminated
Origin on fileAnaheim CA 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.