DRUG RECALL - Fosinopril Sodium and Hydrochlorothiazide Tablets used for Treatment of High Blood Pressure and Congestive Heart Failure
October 11, 2013, Sandoz, Inc. issued a recall of Fosinopril Sodium and Hydrochlorothiazide. The single lot affected by the recall was #CU0856 with the expiration date of 04/2014. The Fosinopril Sodium and Hydrochlorothiazide recall was due to low Hydrochlorothiazide potency in the drug. There are no health risks that have been reported due to this recall.
Fosinopril Sodium and Hydrochlorothiazide is used for the treatment of high blood pressure by preventing the absorption of salt and relieving fluid retention. Fosinopril Sodium and Hydrochlorothiazide is also used to treat congestive heart failure.
If you have this product, it is suggested that you cease its use and check with the dispensing pharmacy to see if your medication came from the lot that was recalled. If you have any questions about this recall, please contact your local retail pharmacist or speak to your doctor.
For product reimbursement and replacement questions regarding this recall, please call Sandoz Customer Support at 1-800-525-8747.
Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Online - www.fda.gov/medwatch/report.htm
Regular Mail - use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax - 1-800-FDA-0178