Antacid Recall Grows

Three firms are voluntarily recalling ranitidine tablets and capsules over potential product contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA). The latest recalls, announced in the November 20, 2019, US Food and Drug Administration (FDA) Enforcement Report, were initiated by Apotex Inc., Novitium Pharma, and Golden State Medical Supply Inc. 

A widespread ranitidine recall from Dr. Reddy’s Laboratories, prompted by confirmed contamination with NDMA, was included in the November 13, 2019, FDA Enforcement Report.

 “Apotex has learned from the US FDA and other global regulators that some ranitidine medicines, including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called NDMA at low levels,” Apotex stated in a September 25, 2019, announcement. “To date, Apotex has not received any reports of adverse events related to use of the product.”

Apotex is recalling the following unexpired ranitidine products, which were distributed throughout the United States:

• Walgreens maximum-strength Wal-Zan 150 ranitidine tablets, 150 mg, 200 tablets (NDC 0363-1030-07), 24 tablets (NDC 0363-1030-02), 95 tablets (NDC 0363-1030-09), and 65 tablets (NDC 0363-1030-06);
• Walgreens regular-strength Wal-Zan 75 ranitidine tablets, 75 mg, 30 tablets (NDC 0363-1029-03);
• Walmart Equate maximum-strength ranitidine tablets, 150 mg, 130 tablets, twin packs (NDC 49035-100-07) and single packs (NDC 49035-100-00);
• Walmart Equate maximum-strength ranitidine tablets, 150 mg, cool mint, sugar free, 65 tablets (NDC 49035-117-06);
• Rite Aid Pharmacy maximum-strength ranitidine tablets, 150 mg, cool mint, sugar free, 24 tablets (NDC 11822-6107-4); and
• Rite Aid Pharmacy maximum-strength ranitidine tablets, 150 mg, 50 tablets (NDC 11822-6052-1), 65 tablets (NDC 11822-6052-2), 95 tablets (NDC 11822-4727-3), and 24 tablets (NDC 11822-6051-8). 

Novitium Pharma is recalling the following unexpired ranitidine products, which were distributed throughout the United States:

• ranitidine capsules, 150 mg, 60 capsules (NDC 70954-001-20) and 500 capsules (NDC 70954-001-40); and
• ranitidine capsules, 300 mg, 30 capsules (NDC 70954-002-10) and 100 capsules (NDC 70954-002-40). 

Golden State Medical Supply is recalling the following ranitidine products, which were distributed in Arizona, Iowa, Massachusetts, and Missouri:

• ranitidine capsules, 150 mg, 500-count bottles (NDC 51407-097-05), manufactured by Novitium Pharma and packaged by Golden State Medical Supply, from lots GS023970 (Exp. 10/31/20), GS026108 (Exp. 10/31/20), GS026099 (Exp. 10/31/20), GS026838 (Exp. 10/31/20), GS025702 (Exp. 10/31/20), GS027272 (Exp. 10/31/20), and GS027273 (Exp. 5/31/21); and
• ranitidine capsules, 300 mg, 100-count bottles (NDC 51407-097-05), manufactured by Novitium Pharma and packaged by Golden State Medical Supply, from lots GS023971 (Exp. 10/31/20), GS025527 (Exp. 10/31/20), GS025526 (Exp. 10/31/20), GS026114 (Exp. 10/31/20), GS025813  (Exp. 10/31/20), GS026189 (Exp. 10/31/21), GS027555 (Exp. 7/31/21), GS026190 (Exp. 5/31/21), GS026220 (Exp. 5/31/21), GS026584 (Exp. 5/31/21), GS027139 (Exp. 5/31/21), and GS027554 (Exp. 5/31/21). 

Apotex initiated its recall September 24, 2019. On October 25, 2019, Novitium Pharma issued its recall. After receiving notification of Novitium’s recall, Golden State Medical Supply issued its recall November 6, 2019. By mid-November, the FDA had designated all ranitidine recalls Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

Over-the-counter ranitidine tablets are used to prevent and treat heartburn. Prescription ranitidine capsules are used in the treatment of ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid. 

—Jolynn Tumolo