Additional Antacids Pulled Over NMDA Contamination

AvKARE Inc. and AuroMedics Pharma have joined a number of companies voluntarily recalling ranitidine products because of contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA). The latest recalls were announced in the December 4, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

AvKARE is recalling the following products, which were distributed throughout the United States:

• ranitidine tablets (prescription), 150 mg, manufactured by Amneal Pharmaceuticals of New York, 1000 tablets (NDC 42291-724-10), from lots HK16617A (Exp. 11/30/19), HL03917A (Exp. 11/30/19), HL04017A (Exp. 11/30/19), HM06017A (Exp. 11/30/19), HM06117A (Exp. 11/30/19), HB03518A (Exp. 03/31/20), HB03618A (Exp. 3/31/20), HC14018A (Exp. 4/30/20), HC14118A (Exp. 4/30/20), HC14218A (Exp. 4/30/20), HC14318A (Exp. 4/30/20), HC14418A (Exp. 4/30/20), HC14518A (Exp. 5/31/20), HH04518A (Exp. 8/31/20), HH04618A (Exp. 8/31/20), HH04718A (Exp. 8/31/20), HH04818A (Exp. 8/31/20), HH04918A (Exp. 8/31/20), HK02718A (Exp. 10/31/20), HK06918A (Exp. 10/31/20), HL07418A (Exp. 11/30/20), HL07518A (Exp. 11/30/20), HA00419A (Exp. 12/31/20), HA00519A (Exp. 12/31/20), HA02719A (Exp. 12/31/20), HA02819A (Exp. 12/31/20), HA2719A (Exp. 12/31/20), HC05019A (Exp. 3/31/21), HC05119A (Exp. 3/31/21), HC05911A (Exp. 3/31/21), HE03319A (Exp. 4/30/21), HE03419A (Exp. 4/30/21), HE05419A (Exp. 4/30/21), HG02319A (Exp. 6/30/21), HG02419A (Exp. 6/30/21), and HG02619A (Exp. 6/30/21);
• ranitidine tablets (prescription), 150 mg, manufactured by Amneal Pharmaceuticals of New York, 180 tablets (NDC 42291-724-18), from lots 21570 (Exp. 3/31/20), 21571 (Exp. 3/31/20), 22190 (Exp. 3/31/20), 22192 (Exp. 5/31/20), 22497 (Exp. 5/31/20), 22620 (Exp. 5/31/20), 22999 (Exp. 9/30/20), 23000 (Exp. 9/30/20), 24158 (Exp. 3/31/21), and 24159 (Exp. 4/30/21);
• ranitidine tablets (prescription), 150 mg, manufactured by Amneal Pharmaceuticals of New York, 60 tablets (NDC 42291-724-60), from lots 21241 (Exp. 3/31/20), 21680 (Exp. 3/31/20), 22193 (Exp. 3/31/20), 22657 (Exp. 3/31/20), 23001 (Exp. 9/30/20), 23002 (Exp. 9/30/20), and 24157 (Exp. 4/30/21);
• ranitidine tablets (prescription), 300 mg, 250 tablets (NDC 42291-725-25), from lots 21307 (Exp. 2/29/20), 21309 (Exp. 2/29/20), 21528 (Exp. 2/29/20), 21527 (Exp. 2/29/20), 22247 (Exp. 6/30/20), 23214 (Exp. 9/30/20), 23243 (Exp. 9/30/20), 23244 (Exp. 11/30/20), 24198 (Exp. 1/31/21), 24199 (Exp. 1/31/21), and 24289 (Exp. 1/31/21); and
• ranitidine tablets (prescription), 300 mg, 30 tablets (NDC 42291-725-30) from lots 22291 (Exp. 6/30/20), 23215 (Exp. 9/30/20), and 23776 (Exp. 1/31/21).  

AuroMedics Pharma is recalling the following products, which were distributed throughout the United States:

• Aurobindo ranitidine capsules (prescription), 150 mg, 60-count bottle (NDC 59651-144-60), distributed by Aurobindo Pharma, from lots RA1518001-A (Exp. 7/20), RA1518002-A (Exp. 7/20), RA1518005-B (Exp. 8/20), RA1518006-A (Exp. 8/20), and RA1519003-A (Exp. 5/21);
• Aurobindo ranitidine capsules (prescription), 150 mg, 500-count bottle (NDC 59651-144-05), distributed by Aurobindo Pharma, from lots RA1518002-B (Exp. 7/20), RA1518003-A (Exp. 7/20), RA1518004-A (Exp. 8/20),  RA1518005-A (Exp. 8/20), RA1518007-A (Exp. 9/20), RA1518008-A (Exp. 9/20), RA1518009-A (Exp. 9/20), RA1518010-A (Exp. 10/20), RA1518011-A (Exp. 11/20), RA1518012-A (Exp. 11/20), RA1518013-A (Exp. 11/20), RA1518014-A (Exp. 11/20), RA1518015-A (Exp. 11/20),  RA1519003-B (Exp. 5/21), and RA1519004-A (Exp. 5/21);
• Aurobindo ranitidine capsules (prescription), 300 mg, 30-count bottle (NDC 59651-145-30), distributed by Aurobindo Pharma, from lots RA3018001-A (Exp. 7/20), RA3018002-A (Exp. 7/20), RA3018003-A (Exp. 7/20), RA3018004-A (Exp. 8/20), RA3018005-A (Exp. 8/20), RA3018006-A (Exp. 8/20), RA3018007-A (Exp. 9/20), RA3018008-A (Exp. 9/20), RA3018009-A (Exp. 9/20), RA3018010-A (Exp. 10/20), RA3019001-A (Exp. 1/21), RA3019002-A (Exp. 1/21), and RA3019003-A (Exp. 5/21);
• ranitidine syrup (ranitidine oral solution, prescription), 15 mg/mL (75 mg/5mL), 474-mL bottle (NDC 65862-431-74), distributed by Aurobindo Pharma, from lots UI1519001-A, UI1519002-A, UI1519003-A, and UI1519004-A; and
• DG Health acid reducer ranitidine tablets, 150 mg, 8-count carton (NDC 55910-092-79), distributed by Dolgencorp, from lot NBSB19001DA3 (Exp. 2/21). 

The recalls were initiated by AuroMedics Pharma on November 6, 2019, and by AvKARE on  November 14, 2019. On November 26, 2019, the FDA designated them Class II, communicating use of the products could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

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

—Jolynn Tumolo