Additional Recalls for Blood Pressure Drug Announced

More valsartan recalls, prompted by the detection of a carcinogen impurity in an active pharmaceutical ingredient (API) used to manufacture the drug, were announced in the September 5, 2018, US Food and Drug Administration (FDA) Enforcement Report. The recalls have been designated Class II by the FDA, signaling use of the affected drugs may cause temporary or medically reversible adverse health consequences. While remote, a possibility of serious harm also exists.

The latest valsartan recalls were voluntarily initiated in mid-August by AvKARE Inc., Torrent Pharma Inc., and RemedyRepack Inc.

AvKARE Inc. is recalling several strengths of valsartan tablets, which were distributed throughout the United States:

• 50-count blister packs of 40-mg valsartan tablets, USP (NDC 50268-783-15), from lots 18491 (Exp. 10/18), 19531 (Exp. 4/19), 20168 (Exp. 5/19), 20671 (Exp. 8/19), 21049 (Exp. 10/19), and 21635 (Exp. 10/19);
• 50-count blister packs of 80-mg valsartan tablets, USP (NDC 50268-784-15), from lots 18492 (Exp. 11/18) and 20169 (Exp. 5/19);
• 50-count blister packs of 160-mg valsartan tablets, USP (NDC 50268-785-15), from lots 17717 (Exp. 7/18), 18493 (Exp. 1/19), and 19761 (Exp. 4/19); and
• 30-count blister packs of 320-mg valsartan tablets, USP (NDC 50268-786-13), from lots 17718 (Exp. 7/18), 18700 (Exp. 1/19), 19133 (Exp. 2/19), and 19532 (Exp. 4/19).

Torrent Pharma Inc. is recalling various valsartan and valsartan combination drugs, which were distributed throughout the United States:

• 90-count bottles of 80-mg valsartan tablets, USP (NDC 13668-068-90), from batches BV46C007, BV46C008, BV46C009, BV46C010, BV46C011, BV46C012, BV46C003, and BV46C006;
• 90-count bottles of 160-mg valsartan tablets, USP (NDC 13668-069-90), from batches BV47C005, BV47C006, BV47D001, BV47C003, and BV47C004;
• 90-count bottles of 320-mg valsartan tablets, USP (NDC 13668-070-90), from batches BV48D001 and BV48D002;
• 30-count bottles of amlodipine and valsartan tablets, USP, 5 mg/160 mg (NDC 13668-207-30), from batches BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, and BV53C005;
• 30-count bottles of amlodipine and valsartan tablets, USP, 5 mg/320 mg (NDC 13668-205-30), from batches BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, and BV84C009;
• 30-count bottles of amlodipine and valsartan tablets, USP, 10 mg/160 mg (NDC 13668-206-30), from batches BV65D002, BV65C002, BV65C003, BV65C004, and BV65D001;
• 30-count bottles of amlodipine and valsartan tablets, USP, 10 mg/320 mg (NDC 13668-204-30), from batches BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, and BV77C010;
• 30-count bottles of amlodipine, valsartan, and hydrochlorothiazide tablets, USP, 10 mg/320 mg/25 mg (NDC 13668-325-30), from batches BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, and BBX2C007;
• 30-count bottles of amlodipine, valsartan, and hydrochlorothiazide tablets, USP, 5 mg/160 mg/12.5 mg (NDC 13668-326-30), from batches BBY1E001, BBY1E003, BBY1C002, BBY1E002, and BBY1D001;
• 30-count bottles of amlodipine, valsartan, and hydrochlorothiazide tablets, USP, 5 mg/160 mg/25 mg (NDC 13668-329-30), from batches BBY4D004, BBY4E001, BBY4D001, BBY4D002, and BBY4D003;
• 30-count bottles of amlodipine, valsartan, and hydrochlorothiazide tablets, USP, 10 mg/160 mg/12.5 mg (NDC 13668-327-30), from batches BBY2E001, BBY2D001, and BBY2D002; and
• 30-count bottles of amlodipine, valsartan, and hydrochlorothiazide tablets, USP, 10 mg/160 mg/25 mg (NDC 13668-328-30), from batches BBX9D004, BBX9E001, BBX9D001, BBX9D002, and BBX9D003.

RemedyRepack Inc. is recalling 90-count bottles of amlodipine, valsartan, and hydrochlorothiazide tablets, 10 mg/320 mg/25 mg (NDC 70518-1220-0), from lot B0476653-080218 (Exp. 8/19). The bottles were distributed in South Carolina.

A full list of valsartan recalls is available on the FDA website. Valsartan is a prescription angiotensin receptor blocker used to treat patients with high blood pressure and congestive heart failure.

—Jolynn Tumolo

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