A batch of blood pressure medication is being recalled after it was potentially mixed up with a drug that could be deadly to some heart patients.
A shipment of Hydrochlorothiazide Tablets USP 12.5 mg distributed by Accord Healthcare Inc. is being voluntarily recalled after a 100 count bottle actually contained 100 Spironolactone Tablets USP 25 mg.
The bottle was a part of batch PW05264, and the FDA says it was a potential mix up of labeling.
“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,” the recall notice reads.
Accord found out about the mix up after a pharmacy called to report it.
Spironolactone is used to treat a variety of conditions including high blood pressure, congestive heart failure and conditions where there are low levels of potassium in the blood, among other things.
Hydrochlorothiazide is used to treat high blood pressure “as the sole therapeutic agent or to enhance the effectiveness of other anti-hypertensive drugs in the more severe forms of hypertension,” the recall notice reads.
But, if one drugs is used instead of the other in particular patients, the results can be life-threatening, according to the FDA.
“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,” the recall notice states.
But, Accord said they have not received any reports of adverse reaction related to the mix up.
How to identify the Hydrochlorothiazide Tablets:
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 are in possession of Accord Hydrochlorothiazide that does not match this image or if you are unsure, please return to your pharmacy or healthcare provider for confirmation.
Accord is notifying its Wholesalers, Distributors and Retailers by letter and is arranging for return of all recalled products. Wholesalers, Distributors, and Retailers that have product which is being recalled should discontinue distribution of the product and notify consumers. Consumers that have the product should return the product to the pharmacy.
Consumers/Pharmacies with questions regarding this 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178