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Class II · ModerateRecall completed

Ranitidine

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

Does this affect you?
Check your lot numberLot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21
Where it was soldDistributed to Physicians in the following states: CA, FL, NC, 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 / forH J Harkins Company Inc dba Pharma Pac
Show the full FDA record
Full product labelRanitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
Recalling firmH J Harkins Company Inc dba Pharma Pac
DistributionDistributed to Physicians in the following states: CA, FL, NC, and SC.
Quantity7,212 tablets
Recall initiated2020-01-06
Report date2020-01-29
Recall completed2023-12-15
Recall numberD-0793-2020
ClassificationClass II
FDA statusTerminated
Origin on fileGrover Beach 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.