US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 24, 2022 (5 years ago)

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61

Recalling firm
The Harvard Drug Group
NDC code
0904-6440-61
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0653-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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