The U.S. Food and Drug Administration says Accord Healthcare Inc. is issuing a nationwide recall of Hydrochlorothiazide tablets USP 12.5 mg due to a labeling mix-up.
The company is 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 the tablets 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, the company is recalling this individual lot from the market.
Accord believes no other lots of Hydrochlorothiazide tablets are involved in the mix-up. Company officials say they became aware of the finding through a product complaint reported from a pharmacy.
Use of Spironolactone tablets instead of Hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in certain individuals resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals.
To date, Accord has not received any reports of adverse events related to this recall.
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.
If you have Accord Hydrochlorothiazide that does not match this image or if you are unsure, please return to your pharmacy or healthcare provider for confirmation.
Consumers and pharmacies with questions regarding the recall can contact Accord Healthcare, Inc. by phone at 1-855-869-1081, fax: 1-817-868-5362 or e-mail at firstname.lastname@example.org Monday to Friday during business hours 8 am to 5 pm EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Hydrochlorothiazide was approved by the FDA in 1959.