Accord Healthcare, Inc. has issued a consumer-level, nationwide recall of a single lot (PW05264) of mislabeled hydrochlorothiazide 12.5 mg tablets, per U.S. Food and Drug Administration (FDA). It was discovered, through a patient complaint, that a 100-count bottle hydrochlorothiazide contains 100 spironolactone 25 mg tablets.
Similar to hydrochlorothiazide, spironolactone is also used as a blood pressure drug. However, the use of spironolactone could increase potassium levels, which could be fatal for some patients. It could even cause arrhythmia when taken in larger doses. It is also used to treat liver, heart and kidney failure, according to the FDA. Aldactone and CaroSpir are the brand names that spironolactone is sold in, per NBC News.
As of now, there are no reports of patients getting sick because of this mishap.
Accord believes that no other lots of hydrochlorothiazide have been affected by the mislabeling, however, it asks consumers to be more cautious especially if this drug is prescribed to them. The company also calls for wholesalers and distributors to halt the distribution of this drug and immediately notify their customers.
For guidance, FDA also included this description of the drug in its announcement: “Accord’s Hydrochlorothiazide Tablets USP 12.5 mg are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side.”
Accord also encourages both consumers and distributors to contact them about this recall during business hours—Monday through Friday 8 a.m. to 5 p.m. EST. You can reach them by:
- phone: at 1-855-869-1081
- fax: 1-817-868-5362
- e-mail: firstname.lastname@example.org
Accord Healthcare, Inc. is a generic pharmaceutical company that develops and manufactures products for different areas of medicine. It serves consumers from North America, Europe, South America, Australia, New Zealand, South Africa and the MENA region.
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