Drug & medication recalls Moderate risk

The Harvard Drug Group recalls hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARM…

Recall date
February 24, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0653-2022
FDA classification
Class II
Brand / firm
The Harvard Drug Group
Sold / distributed
Nationwide within USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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