Reported Mar 23, 2022 · Terminated

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR…

The Harvard Drug Group

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group · 17187 N Laurel Park Dr Ste 300 · Livonia, MI · 48152-2600

Is this the product you have?

  • hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only
  • Distributed byMAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Lot codes and dates
    • Lot #: T03755
    • T03756
    • Exp. Date 03/2023
Amount recalled
5,953 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 16, 2023 · Data as of Sep 19, 8:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.