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Recall Observatory FDA recall evidence

Drug product

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

D-0653-2022

February 24, 2022

Class II

Product summary

Firm
The Harvard Drug Group
Event
Event 89663
Status
Terminated
Classification
Class II
Quantity
5,953 cartons
Official record key
drug-enforcement:D-0653-2022

Official wording

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

Code information: Lot #: T03755, T03756, Exp. Date 03/2023

Distribution pattern: Nationwide within USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification