Commercial and Tufts Health Direct

Ranitidine tablets for the treatment of GERD, heartburn, and ulcer

On January 6 and 7, 2020, Denton Pharma, Inc. dba Northwind Pharmaceuticals, and Appco Pharma LLC, manufacturers of ranitidine, issued a voluntary recall of ranitidine capsules and 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. 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, contact Denton Pharma, Inc. dba Northwind Pharmaceuticals, Appco Pharma LLC or the FDA's MedWatch Program.

Manufacturers

• Denton Pharma, Inc. dba Northwind Pharmaceuticals: 1.800.722.0772, Monday through Friday, 9 a.m. – 5 p.m., US EST
• Appco Pharma LLC : 732.253.7735, Monday through Friday, 8 a.m. and 6 p.m. (EST) or email: pv@appcopharma.com.

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

• To report by phone, call toll-free: 1.800.FDA (332).1088
• To fax report, 1.800.FDA(332)0178
• To report online, visit the FDA website

Affected NDCs

Denton Pharma, Inc. dba Northwind Pharmaceuticals

Product	NDC	Affected Lots
Ranitidine Tablets, USP 150mg	70934-017-04 70934-017-20 70934-017-24 70934-017-30 70934-017-90	All Unexpired Lots
Ranitidine Tablets, USP 300mg	70934-287-15 70934-287-90	All Unexpired Lots

Appco Pharma LLC

Description	NDC	Affected Lots
Ranitidine Capsules 300 mg	62559-691-30	All Unexpired Lots
Ranitidine Capsules 150 mg	62559-690-60 62559-690-05	All Unexpired Lots