Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Aug 28, 2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.