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

FDA recall notice · announced March 23, 2022 · The Harvard Drug Group

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Nationwide within USA
Lot/code information: Lot #: T03755, T03756, Exp. Date 03/2023
Quantity: 5,953 cartons
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.