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FDAFebruary 24, 2022drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

harvard drugharvard

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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