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Class II · ModerateRecall completed

Ranitidine Hydrochloride (powder)

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

Does this affect you?
Check your lot numberLot #:11E0585, Exp. October 2023
Where it was soldThe recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
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 / forSpectrum Laboratory Products
Show the full FDA record
Full product labelRanitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
Recalling firmSpectrum Laboratory Products
DistributionThe recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
QuantityN/A
Recall initiated2020-01-14
Report date2020-02-12
Recall completed2023-12-05
Recall numberD-0825-2020
ClassificationClass II
FDA statusTerminated
Origin on fileGardena CA United States

Related

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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.