FDAFDA · Food and drugs·Recall number D-0653-2022
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
Published March 23, 2022 · Recall initiated: February 24, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group
- Distributor
- Nationwide within USA
- Lot
- Lot #: T03755, T03756, Exp. Date 03/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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