The bottle at issue was supposed to contain Hydrochlorothiazide Tablets USP 12.5 mg — a prescription drug used for the treatment of high blood pressure (hypertension). Instead, the bottle contained Spironolactone Tablets USP 25 mg — a drug used to treat congestive heart failure, cirrhosis of the liver and other health problems, the FDA warning letter said.
The agency says “limited” to “life-threatening” effects, depending on the individual, may occur if the drugs are mixed up.
Accord Healthcare Inc., the company that manufactures both drugs, said the recall only affects one lot of Hydrochlorothiazide, PW05264.
Accord’s Hydrochlorothiazide Tablets USP 12.5 mg tablets are supposed to be round and light orange or peach in color. They have a “H” and a “1” printed on opposite sides, FDA said.
If you have any Hydrochlorothiazide tabs that do not match this description, FDA advises you to consult your healthcare provider immediately.
To date, there have been no injuries or other adverse events associated with the recall, Accord said.
Source: USA Today