ALL Ranitidine Products Recall – Immediate Action Needed

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Date: April 3, 2020
To: Health Plan of San Joaquin (HPSJ) Pharmacies and Providers & Practices
From: HPSJ Pharmacy Department
Subject: ALL Ranitidine Products Recall – Immediate Action Needed
Business: Medi-Cal

We are sending this alert because your patient(s) may have filled a prescription for
Ranitidine within the last six months (180 days).

Issue:
The FDA is requesting manufacturers to withdraw all prescription and over-the-counter
(OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as NNitrosodimethylamine (NDMA) in ranitidine medications. NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than normal room temperature, it may result in consumer exposure to unacceptable levels of this impurity.

HPSJ is now contacting all HPSJ members who have filled a prescription for Ranitidine
within the last six months (180 days).

Recommendation:
Health care professionals and patients are encouraged to report adverse events or side
effects related to the use of these products to the FDA’s MedWatch Safety Information and
Adverse Event Reporting Program:
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

Due to the current COVID-19 pandemic, the FDA recommends patients and consumers NOT take their medicines to a drug take-back location, but follow the FDA’s recommended steps which include ways to safely dispose of these medications at home.

This table shows the product subject to recall.

Product/Dosage NDC Number Lot Number
Ranitidine Tablets/Capsules/Liquid All All

If you have questions, please contact our HPSJ Customer Service team (Monday-Friday, 8 a.m. –  5 p.m. PST): 209-942-6320.

Posted on April 3rd, 2020 and last modified on April 6th, 2020.

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