Company Announcement Date: December 17, 2019

FDA Publish Date: December 17, 2019

Product Type: Drugs

Reason for Announcement: NDMA (Nitrosodimethylamine) impurity

Company Name: Glenmark Pharmaceuticals, Inc.

Brand Name: Glenmark

Product Description: Ranitidine Tablets 150mg and 300mg

Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.

The recalled lots of Ranitidine Tablets 150 mg and 300 mg, which are listed in Attachment B, are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.

Glenmark’s Ranitidine Tablets 150 mg and 300 mg are manufactured at two approved manufacturing facilities. Of the 928 recalled lots of Ranitidine Tablets, USP, 16 lots were manufactured by Glenmark Pharmaceuticals Ltd., Goa, India and 912 lots were manufactured by Strides Pharma Science Limited, Puducherry, India. Ranitidine Tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

Glenmark is committed to product and consumer safety. It will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers. As a further precautionary measure, Glenmark ceased distribution of its Ranitidine products in the United States while it continues its efforts to test and investigate in cooperation with the FDA.

To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall. The Ranitidine Tablets, USP, distributed by Glenmark are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The Ranitidine Tablets, USP subject to the recall can be identified by the NDC number on the product label. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall:

The affected Ranitidine Tablets were distributed directly to Wholesalers, Distributors, Retailers and Repackagers nationwide.

The 150mg products product are packaged in bottle packs of 60’s, 100’s and 500’s, whereas, the 300mg products are packaged in bottle packs of 30’s, 100’s and 250’s. Photos are attached below.

Glenmark is notifying its direct customers by mailing (UPS Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lot immediately.

Customers who purchased the impacted product directly from Glenmark and consumers can call Qualanex at 1-888-504-2012 Monday – Friday, 9:00 am – 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use and consult with their physician or healthcare provider about treatment options.

Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Glenmark Drug Safety by phone at Glenmark customer service center at 1-888-721- 7115, Monday thru Friday, 9:00 am – 6:00 pm, US EST, or e-mail at GlobalCustomerService@glenmarkpharma.com. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.