Class IITerminated

HydrALAZINE Hydrochloride Tablets recall

FDA recall D-0324-2024 · initiated Feb 9, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Details

Product: HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Recalling company: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: The product was distributed nationwide within the United States.
Initiated: Feb 9, 2024
FDA report date: Feb 21, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0324-2024 ↗

← All drug recalls