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  4. Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market
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COMPANY ANNOUNCEMENT

Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Contains N-Nitrosodimethylamine (NDMA)
Company Name:
Dr. Reddy’s Laboratories Ltd.
Brand Name:
Brand Name(s)
Dr. Reddy’s, Kroger, Walgreens, and others
Product Description:
Product Description
Ranitidine Tablets & Capsules

Company Announcement

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries, together referred to as “Dr. Reddy’s”) confirms it had intiatiated a voluntary nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.  This recall follows the USFDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of ranitidine. To date, Dr. Reddy’s has not received any reports of adverse events related to the recall of Dr. Reddy’s Ranitidine products. The recall includes all quantities in the US that are within expiry.

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 and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine is available as an over-the-counter (OTC) and prescription drug. Over-the-counter (OTC) ranitidine tablets are used to relieve heartburn associated with acid indigestion and sour stomach. OTC Ranitidine Tablets are also used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. Prescription ranitidine capsules are prescribed for the short-term treatment of active duodenal ulcer; maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers; treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis); short-term treatment of active, benign gastric ulcer; maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers; treatment of GERD (Gastroesophageal reflux disease); treatment of endoscopically diagnosed erosive esophagitis; and for maintenance of healing of erosive esophagitis.

Dr. Reddy’s Ranitidine products can be identified by NDC numbers on the product label. All Ranitidine products with expiration dated September 2019 to March 2022 are being recalled:

Description Strength Type Pack NDC
Ranitidine Capsules 150mg, 60 150 mg Rx 60 ct bottle 5511112960
Ranitidine Capsules 150mg, 500 150 mg Rx 500 ct bottle 5511112905
Ranitidine Capsules 300mg, 30 300 mg Rx 30 ct bottle 5511113030
Ranitidine Capsules 300mg, 100 300 mg Rx 100 ct bottle 5511113001
Rantidine Tablets, USP 150mg,190(2x95)Tray (Sam’s Club) 150 mg OTC 190 ct (2x95) tray 150062076
(UPC Code 078742089720)
Ranitidine Tablets, USP 150mg, 95 (Walgreens) 150 mg OTC 95 ct bottle 0363-0010-62
Ranitidine Tablets, USP 150 mg 220 CT Btl (Walmart) 150 mg OTC 220 ct bottle 49035-404-65
Ranitidine Tablets, USP 150mg 50ct Btl (Kroger) 150 mg OTC 50 ct bottle 30142-505-50
Ranitidine Tablets, USP 150mg 24ct Btl (Kroger) 150 mg OTC 24 ct bottle 30142-505-34
Ranitidne Tablets, USP 150mg 65 Ct Btl (Walgreens) 150 mg OTC 65 ct bottle 0363-0010-61
Ranitidine Tablets, USP 150 TAB 65ct BTL CP32 (Walmart) 150 mg OTC 65 ct bottle 49035-404-61
Ranitidine Tablets, USP 150 Tab 200Ct Btl (Walgreens) 150 mg OTC 200 ct bottle 0363-0010-01
Ranitidine Tablets, USP 150mg Tabs Btl, 24 (Walgreens) 150 mg OTC 24 ct bottle 0363-0010-34
Ranitidine Tablets, USP 75 TAB 30ct Bottle NG (CVS) 75 mg OTC 30 ct bottle 69842-871-30
Ranitidine Tablets, USP 75mg Tab 30Ct Btl (Walgreens) 75 mg OTC 30 ct bottle 0363-0131-30
Ranitidine Tablets, USP 75mg Tab 80Ct Btl (Walgreens) 75 mg OTC 80 ct bottle 0363-0131-80
Ranitidine Tablets, USP 75 TAB 80ct Bottle NG (CVS) 75 mg OTC 80 ct bottle 69842-871-80
Ranitidine Tablets, USP 75 TAB 160ct Bottle NG (CVS) 75 mg OTC 160 ct bottle 69842-871-37
Ranitidine Tablets, USP 75mg 30ct Btl (Kroger) 75 mg OTC 30 ct bottle 30142-131-30
Ranitidine Tablets, USP 150 TAB 24ct BTL (CDMA) 150 mg OTC 24 ct bottle 63868-480-24
Ranitidine Tablets, USP 150 Tablet 130ct Bottle NV (Walmart) 150 mg OTC 130 ct bottle 49035-404-13
Ranitidine Tablets, USP 150 TAB 50ct BTL (CDMA) 150 mg OTC 50 ct bottle 63868-480-50
Ranitidine Tablets, USP 75 Tab 60ct Btl (Dr. Reddy’s) 75 mg OTC 60 ct bottle 55111-131-60
Ranitidine Tablets, USP 75 TAB 60ct BTL (CDMA) 75 mg OTC 60 ct bottle 63868-482-60
Ranitidine Tablets, USP 75 TAB 30ct BTL (CDMA) 75 mg OTC 30 ct bottle 63868-482-30
Ranitidine Tablets, USP 150mg Tablets 24ct BTL00 (Dr. Reddy’s) 150 mg OTC 24 ct bottle 55111-404-34
Ranitidine Tablets, USP 150 Tab 95ct Btl (HCA) 150 mg OTC 95 ct bottle 43598-808-62
Ranitidine Tablets, USP 150 Tab 220ct Btl (HCA) 150 mg OTC 220 ct bottle 43598-808-65
Ranitidine Tablets, USP Tab 150mg 40ct Bottle (Target) 150 mg OTC 40 ct bottle 11673-849-40
Ranitidine Tablets, USP 150 Tab 24ct Btl (Thirty Madison) 150 mg OTC 24 ct bottle 71713-203-02
Ranitidine Tablets, USP 150 Tab 95ct Btl (Thirty Madison) 150 mg OTC 95 ct bottle 71713-203-05
Ranitidine Tablets, USP 75mg  (GeriCare) 75 mg OTC All counts 57896-715
Ranitidine Tablets, USP 150mg (GeriCare) 150 mg OTC All counts 57896-717

If consumers have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality concerns experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online. Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Company’s Medical Information Call Center
1-888-375-3784 (1-888-DRL-DRUG)
Media:
Mitali Sarkar
+91-40-49002121
mitali.sarkar@drreddys.com

Product Photos