August 29, 2018
The August 29, 2018, US Food and Drug Administration (FDA) Enforcement Report announced further recalls for valsartan products. Like numerous others in recent weeks, the latest recalls were prompted by a carcinogen impurity detected in an active pharmaceutical ingredient (API) used to manufacture the drug.
A-S Medication Solutions voluntarily initiated a recall for valsartan tablets and valsartan-hydrochlorothiazide tablets distributed across the United States. The recall, which was initiated July 17, 2018, includes the following:
- 80-mg valsartan tablets in 30-count bottles (NDC 54569-6582-0) from lots 7258177 and 7276228 (Exp. 11/30/18), and 7212260 (Exp. 2/28/19);
- 80-mg valsartan tablets in 90-count bottles (NDC 54569-6582-1) from lots 7208140 (Exp. 11/30/18), 7212261, 7221155, and 7222161 (Exp. 2/28/19), 8109171 (Exp. 8/31/19), and 8109170 (Exp. 9/30/19);
- 160-mg valsartan tablets in 30-count bottles (NDC 54569-6583-0) from lots 7285177 (Exp. 2/28/19), 7222163 and 7227175 (Exp. 3/31/19), and 8162190 and 8183227 (Exp. 8/31/19);
- 160-mg valsartan tablets in 90-count bottles (NDC 54569-6583-1) from lots 7207135, 7212280, and 7215073 (Exp. 2/28/19), 7222162 (Exp. 3/31/19), and 8095248 and 8095249 (Exp. 8/31/19);
- valsartan 160 mg and hydrochlorothiazide 12.5 mg tablets in 90-count bottles (NDC 54569-6480-0) from lots 8033130 (Exp. 4/30/19), and 8068192, 8110183, 8080157, and 8190195 (Exp. 7/31/19); and
- valsartan 320 mg and hydrochlorothiazide 25 mg tablets in 90-count bottles (NDC 54569-6488-0) from lots 7293219 (Exp. 1/31/19), 7362231, 8074161, 8110184, 8197215, 8114178, and 8115123 (Exp. 6/30/19), and 7132187, 7160161, 7180150, and 7268239 (Exp. 9/30/18).
Hetero Labs voluntarily initiated a recall for valsartan tablets August 8, 2018. The recall includes all lots with expiration dates between July 2018 and June 2020 for the following products, which were manufactured for Camber Pharmaceuticals Inc. and were distributed nationwide: 40-mg valsartan tablets, USP, 30-count bottles (NDC 31722-745-30); 80-mg valsartan tablets, USP, 90-count bottles (NDC 31722-746-90); 160-mg valsartan tablets, USP, 90-count bottles (NDC 31722-747-90); and 320-mg valsartan tablets, USP, 90-count bottles (NDC 31722-748-90).
Preferred Pharmaceuticals Inc. voluntarily initiated a recall for 90-count bottles of valsartan 320-mg tablets (NDC 68788-6882-9) August 15, 2018. The recalled bottles are from lot G2017F (the recall report did not list an expiration date) and were sent to a distributor in Alabama, who the FDA said may have further distributed the medication at the consumer level.
In mid-August, the FDA designated the A-S Medication Solutions, Hetero Labs, and Preferred Pharmaceuticals recalls Class II. Drugs included in Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
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.
For more Pharmacy Learning Network articles, visit the homepage
To learn about Pharmacy Learning Network Live meetings, click here