Commercial and Tufts Health Direct plans

On December 17, 2019, Glenmark Pharmaceutical Inc., manufacturer of ranitidine, issued a voluntary recall of ranitidine tablets. This recall was issued because an unexpected impurity was found in these products that may cause health risks.

What do you need to do?

• Do not stop taking your medication without speaking with your doctor.  The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
• Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption

For more information or to report any adverse events or quality problems experienced with the use of this product directly to Glenmark Drug Safety or to the FDA's MedWatch Program.

Manufacturers:

• Glenmark Drug Safety: Glenmark customer service center at 1-888-721- 7115, Monday thru Friday, 9:00 am – 6:00 pm, US EST, or via email at GlobalCustomerService@glenmarkpharma.com. 

To report an adverse event to the FDA Med Watch Program:

• Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
• Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda or submit by fax to 1-800-FDA-0178

Affected NDCs

Product	NDC#	Affected Lots
Ranitidine 150 mg tablets	68462-0248-05 68462-0249-01 68462-0248-60 68462-0248-01	All Unexpired Lots
Ranitidine 300 mg tablets	68462-0249-30 68462-0249-20	All Unexpired Lots