Ajanta Pharma Ranitidine Capsules Withdrawal

4/16/2020

On April 16, 2020, Ajanta Pharma issued a notice that it is conducting a voluntary market withdrawal of ranitidine capsules products. Ajanta Pharma is conducting the withdrawal of these products at the request of the United States Food and Drug Administration (FDA). The FDA requested all manufacturers conduct market withdrawals of all ranitidine products.  The FDA determined that the level of contaminant known as N-Nitrosodimethylamine (NDMA) in some ranitidine products increases over time and when stored at higher than room temperatures, which may result in consumer exposure to unacceptable levels of this impurity.

This withdrawal includes all Ajanta Pharma ranitidine capsules, a list of which is provided here.

The FDA is advising patients taking prescription ranitidine to speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. Please call your doctor right away for advice if you might be using affected medicine. Your doctor knows your medical history and can tell you what to do next. If you need a prescription for a different medicine, please contact your doctor.

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home:

• Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;

• Place the mixture in a container such as a sealed plastic bag;

• Throw away the container in your trash at home; and

• Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.

CVS Caremark? Response: Consistent with the FDA’s guidance, CVS Caremark Mail Service Pharmacies will no longer be filling prescriptions for ranitidine products, including Ajanta Pharma ranitidine capsules.

If you are currently taking Pharmaceutical Associates, Inc. ranitidine syrup products and have questions regarding this recall, please call your doctor or call Ajanta Pharma toll-free at 1-855-664-7744. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.