News


Lot of Hydrochlorothiazide 25 mg Tablets Voluntarily Recalled

by Helios | Aug 03, 2015

Unichem Pharmaceuticals, Inc. is voluntarily recalling one lot of hydrochlorothiazide (HCTZ) 25 mg tablets 1000-count bottle as a precautionary measure due to the identification of a clopidogrel tablet found in a bottle. Although this was an isolated event confined to one pharmacy, the risk of a patient experiencing side effects from clopidogrel, including bleeding and/or bruising, prompted this recall. In addition, missing one dose of HCTZ may result in uncontrolled blood pressure or swelling caused by excess fluid.       

These medications are in different drug classes and work differently.

  • Hydrochlorothiazide is a thiazide diuretic (water pill) used in the management of edema (swelling caused by fluid retention) and high blood pressure.
  • Clopidogrel (Plavix®) is an antiplatelet medication used to thin blood and help prevent stroke, heart attack, and other heart problems.

Unichem has not received any reports of adverse events related to this recall to date.

The affected Lot # GHYL15028 with an expiration date of April 2018 was distributed nationwide to wholesalers, retailers, and pharmacies from May 21-28, 2015. Claimants should not ingest any tablets from this lot and are instructed to return their prescription bottles to the place of purchase. If claimants have experienced any problems that may be related to using this medication or are not sure if they received the recalled lot, they should contact their physician, healthcare provider, or pharmacist. Unichem is in the process of notifying distributors and customers and arranging for the return of the recalled product.

If you have any questions regarding this Medication Recall Notice or potentially impacted claimants, contact your account manager or our Clinical Services team at ask-a-pharmacist@helioscomp.com.

Click here to read the MedWatch Safety Alert

Reference:

FDA MedWatch Safety Alert: Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall – Potential Presence of Foreign Tablets Contamination. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456881.htm. Accessed August 3, 2015.