HydroDIURIL FDA Alerts

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.

Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. 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.

Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

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. An image of this product is available here.

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 rxrecalls@inmar.com 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.accessdata.fda.gov/scripts/medwatch/index.cfm
• Regular Mail or Fax 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination

ISSUE: Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product.

The risk associated with mistakenly taking a Clopidogrel tablet instead of a Hydrochlorothiazide tablet is the increased probability of experiencing Clopidogrel's side effects which include bleeding and/or bruising. Patients with active bleeding or who are allergic to Clopidogrel or any component of the formulation may experience more serious adverse health consequences as a result of unknowingly consuming Clopidogrel. Additionally, missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema). 

BACKGROUND: Hydrochlorothiazide tablets are indicated for the management of high blood pressure and edema and are packaged in 1000-count bottles. The affected Hydrochlorothiazide tablets include Lot # GHYL15028 - Expiration April, 2018, and was distributed nationwide directly to wholesalers, retailers, and pharmacies from May 21 - 28, 2015. As per Unichem's internal investigation, this episode is an isolated event noted at one pharmacy and confined to the recalled lot. Unichem has not received any reports of adverse events related to this recall to date.

RECOMMENDATION:  Consumers should not consume Hydrochlorothiazide Tablets 25 mg 1000's from the lot GHYL15028 which is being recalled and should return to place of purchase. 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. If the consumer is not sure they received the recalled lot, they should contact the pharmacy that dispensed the product to them.
Unichem is notifying its distributors and customers by letter, overnight FedEx and emails. Unichem is also arranging for return of all recalled products.

Adverse reactions or quality problems experienced with the use of this product may be reported to to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form 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.

[07/30/2015 - Press Release - Unichem Pharmaceuticals]