Hypertension Products Recalled

Multiple firms have announced new recalls of losartan products because the carcinogenic substance N-nitrosodimethylamine (NDEA) was identified in an active pharmaceutical ingredient used to manufacture the drug. The recalls were included in the March 27, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

Macleods Pharma USA Inc. is recalling losartan potassium and hydrochlorothiazide tablets, 100 mg/25 mg, 90-count bottles (NDC 33342-0052-10), from lot BLM715A (Exp. 7/19). The recalled tablets were distributed in New Jersey, New York, and Florida. 

Camber Pharmaceuticals Inc. is recalling the following losartan products, which were manufactured by Hetero Labs Limited and distributed throughout the United States: 

• losartan potassium tablets, 25 mg, 90-count bottles (NDC 31722-700-90), from lots LOP17026B, LOP17050, LOP1705, LOP17052, and LOP17053 (Exp. 9/19); LOP17061 (Exp. 10/19); and LOP18035 and LOP18036 (Exp. 12/19); 
• losartan potassium tablets, 25 mg, 500-count bottles (NDC 31722-700-05), from lot LOP17026 (Exp. 9/19); 
• losartan potassium tablets, 25 mg, 1000-count bottles (NDC 31722-700-05), from lots LOP17006 (Exp. 5/19); LOP17025 (Exp. 9/19); LOP17068 (Exp, 10/19); LOP18037, LOP18038, and LOP18039 (Exp. 12/19); and LOP18057 (Exp. Jan-20); 
• losartan potassium tablets, 50 mg, 30-count bottles (NDC 31722-701-30), from lots LOP17028C (Exp. 9/19) and LOP17064A (Exp. 11/19); 
• losartan potassium tablets, 50 mg, 90-count bottles (NDC 31722-701-90), from lots LOP17027 (Exp. 9/19); LOP17063 and LOP17093 (Exp. 11/19); and LOP17094, LOP17095, LOP17097A, LOP17105, and LOP17107 (Exp. 12/19); and 
• losartan potassium tablets, 50 mg, 1000-count bottles (NDC 31722-701-10), from lots LOP17004 (Exp. 12/19); LOP17028B (Exp. 9/19); LOP17048 and LOP17049 (Exp. 10/19); LOP17056, LOP17073, LOP17074, and LOP17076 (Exp. 11/19); LOP17096 (Exp. 12/19); LOP18077A, LOP18078, LOP18079, and LOP18080 (Exp. 2/20); and LOP18081, LOP18084, LOP18095, and LOP18096 (Exp. 3/20). 

AvKare Inc. is recalling the following products, which were distributed throughout the United States: 

• losartan potassium tablets, 50 mg, 50 tablets (5 x 10) unit dose boxes (NDC 50268-517-15), from lots 20961 (Exp. 9/19) and 20477 (Exp. 8/19); and 
• losartan potassium and hydrochlorothiazide tablets, 100 mg/12.5 mg, 50 tablets (5 x 10) unit dose boxes (NDC 50268-514-15), from lot 19326 (Exp. 3/31/19). 
• Preferred Pharmaceuticals Inc. is recalling the following products, which were manufactured by Torrent Pharma Inc. and distributed in California, Georgia, and Indiana: 
• losartan potassium tablets, 50 mg, 30-count bottles (NDC 68788-6882-03), from lots C2218C (Exp. 9/20) and D1318E (Exp. 10/20); and
• losartan potassium tablets, 50 mg, 90-count bottles (NDC 68788-6882-09), from lots C2719J (Exp. 9/20) and E1818B (Exp. 10/20).

Legacy Pharmaceutical Packaging is recalling the following products, which were manufactured for Camber Pharmaceuticals and distributed to Wal-Mart distribution centers in Arkansas, California, Georgia, Indiana, and Maryland:

• losartan potassium tablets, 50 mg, 30-tablet bottles (NDC 68645-578-54), from lots 180921 (Exp. 9/19); 180922 (Exp. 10/19); 180923, 180924, and 181118 (Exp. 11/19); 181119 (Exp. 10/19); 181407 (Exp. 11/19); 181408 (Exp. 12/19); 181573, 181725, and 181726 (Exp. 2/20); 181948 (Exp. 3/20); 181960 (Exp. 2/20); and 182385, 182386, and 182387 (Exp. 3/20); and 
• losartan potassium tablets, 100 mg, 30-tablet bottles (NDC 68645-579-54), from lots 180886 (11/19); 180887, 180888, and 180905 (12/19); 181123 (9/19); 181124 (10/19); 181125 (8/19); 181351 (11/19); 181352 (12/19); 181551 (Exp. 11/19); 181628, 181629, 181727, and 181728 (Exp. 6/20); 181890 (Exp. 3/20); 181891 and 181897 (Exp. 6/20); 182114 (Exp. 3/20); and 182119 and 182120 (Exp. 6/20). 

On March 21, 2019, the FDA designated the recalls Class II, signaling use of the affected drugs may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists. 

Losartan is a prescription angiotensin receptor blocker used to treat high blood pressure and to protect kidneys from diabetes-related damage.

—Jolynn Tumolo